Endometriosis: an invisible disease affecting half a million Canadians

  • 500,000+ Canadian girls and women are affected by 1
  • 9 years old is the average diagnosis age in Canada. 1
  • In Canada, individuals with endometriosis often experience a diagnosis delay of more than five 1

 

Montreal, QC, June 17, 2020 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, sponsored a first of its kind cross-sectional, online survey of 30,000 women in Canada aged 18 to 49. Earlier this year, the results were published in the Journal of Obstetrics and Gynaecology Canada (JOGC) in a paper entitled “Prevalence, Symptomatic Burden, And Diagnosis Of Endometriosis In Canada: Cross-Sectional Survey Of 30 000 Women.”1

 

Findings showed that Canadians with endometriosis often experience a diagnosis delay of more than five years. This half decade delay in disease recognition indicates an important unmet need for more timely diagnosis of endometriosis across Canada.1

 

“Often misdiagnosed and mismanaged; endometriosis can have a significant negative impact on a person’s physical and mental health and dramatically hinder their overall quality of life. Women need to know that painful periods are not normal. There are treatment options available, as long as endometriosis is identified quickly. Unfortunately, that is not always the case,” says Dr. Sukhbir Singh, MD, Professor, Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, ON, who is a primary investigator in the study.

 

In Canada, it’s estimated that seven per cent of women will develop endometriosis.1 Endometriosis is a chronic inflammatory disease that predominantly affects women of reproductive age.2 Endometriosis occurs when endometrial tissue grows outside the uterus. Women with endometriosis experience various symptoms including: non-menstrual pelvic pain, pain during intercourse (dyspareunia), heavy menstrual bleeding, pelvic pain, and cramping during menstruation.3 Infertility can also be common with endometriosis.3

 

“The road for an endometriosis patient is long, with various treatments and no cure. I deal with the physical aspect as well as the emotional and mental pull of it all,” said Alexandra Camara, a Canadian living with endometriosis. “I became symptomatic at an early age. My symptoms increased and became more relevant when I was 14, and at 19, I was formally diagnosed. Receiving a proper diagnosis, then later excision surgery, was monumental to symptom management. To help raise awareness, I’m sharing my story to empower women not to suffer in silence.”

 

According to a survey, seven out of ten women experience unresolved – on-going – endometriosis pain.4

Endometriosis is a life-long journey. Often, patients who are diagnosed and on treatment, or have had surgery, still deal with unmanaged pain. It is important for patients to have continuous support, knowledge and access to clinically proven treatments. If still in pain, be your own advocate, seek out options and speak to a health care expert about all treatment options.

 

 

Globally, an estimated 176 million women live with endometriosis.5 “Although there is currently no cure for endometriosis, we are committed to researching and supporting Canadians living with endometriosis in an effort to provide resources and hope for this disease,” said Denis Hello, Vice President and General Manager, AbbVie Canada. “AbbVie has conducted some of the largest clinical trials in endometriosis in the world. We will continue to research the disease’s most common symptoms to support disease management needs.”

 

Resources such as the Endometriosis Network Canada and online chats via #EndoEmpowered can provide important information and foster a sense of community for endometriosis patients in Canada.

 

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

 

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Media:

Eileen Murphy AbbVie Canada 514-449-9788

eileen.murphy@abbvie.com

 

 

1 Prevalence, Symptomatic Burden, and Diagnosis of Endometriosis in Canada: Cross-Sectional Survey of 30 000 Women. Dr. Sukhbir Singh, et al. http://www.jogc.com/article/S1701-2163(19)30980-6/fulltext. Accessed May 2020.

2 YourPeriod.ca. What is Endometriosis? https://www.yourperiod.ca/endometriosis/what-is-endometriosis/ Accessed May 2020.

3 YourPeriod.ca. What are the symptoms of Endometriosis? https://www.yourperiod.ca/endometriosis/what-are-the-symptoms-of- endometriosis/ Accessed May 2020.

4 De Graaff AA, D’Hooghe TM, Dunselman GAJ, Dirksen CD, Hummelshoj L, WERF EndoCost Consortium, Simoens S. The significant effect of endometriosis on physical, mental and social wellbeing: results from an international cross-sectional survey. Hum Reprod. 2013;28(10):2677-2685. Accessed May 2020.

5 David Adamson, G., Kennedy, S., & Hummelshoj, L. (2010). Creating solutions in endometriosis: Global collaboration through the

world endometriosis research foundation. Journal of Endometriosis, 2(1), 3-6. Accessed May 2020.

AbbVie Receives Health Canada Approval for the Combination of VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia

  • VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukemia (CLL).
  • Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLEXTA had clinically meaningful and statistically significant progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.1

 

Montreal, QC, May 5, 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that Health Canada has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.

 

“Venetoclax in combination with obinutuzumab is an effective treatment with a finite treatment duration. The approval by Health Canada is good news, especially for patients that prefer not to remain on therapy indefinitely,” explains Dr. Sue Robinson, MD, FRCPC, Professor, Division of

Hematology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia. “Based on my experience on the CLL14 clinical trial, I am looking forward to prescribing this combination regimen for older patients with previously untreated CLL and/or those who have concomitant medical problems”.

 

This is the third indication for VENCLEXTA, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion in adult patients who have received at least one prior therapy and for whom there are no other available treatment options.1

 

“Lymphoma Canada is pleased with the approval of VENCLEXTA in combination with obinutuzumab by Health Canada for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

 

This most recent approval is based on the primary analysis (median follow up of 28 months) of the Phase 3 CLL14 clinical trial, which demonstrated clinically meaningful and statistically significant progression-free survival (PFS; the time during and after treatment without disease progression, relapse, or death) as assessed by investigators in patients treated with VENCLEXTA plus obinutuzumab compared

 

to patients who received a standard of care chemotherapy regimen of chlorambucil plus obinutuzumab (hazard ratio 0.35; 95% CI (0.23,0.53), p<0.0001, medians not yet reached).1

 

“We are extremely proud of the Health Canada approval of VENCLEXTA in combination with obinutuzumab,” said Denis Hello, General Manager, AbbVie Canada. “This third approval for VENCLEXTA underscores our commitment to develop blood cancer treatments.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and blood2, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.3

 

VENCLEXTA is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the

U.S. and by AbbVie outside of the U.S.

 

About the CLL14 Trial

The randomized, multicenter, open-label, actively controlled Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (DCLLSG), evaluated the efficacy and safety of a combined regimen of VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in patients with previously-untreated CLL and coexisting medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed duration of 12 cycles for VENCLEXTA in combination with six cycles of obinutuzumab. Cycles were comprised of 28 days. The trial enrolled 432 patients, all of whom were diagnosed according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and were previously untreated. The primary efficacy outcome was PFS as assessed by the investigator.4 Key secondary endpoints included MRD-negativity in peripheral blood and bone marrow, and overall and complete response rates.4,5

 

About AbbVie Care

Canadians prescribed VENCLEXTA can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

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Media:

Eileen Murphy AbbVie Canada 514-449-9788

eileen.murphy@abbvie.com

 

 

 

1 Venclexta Product Monograph. AbbVie Corporation, Canada. https://www.abbvie.ca/content/dam/abbvie- dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed April 30, 2020.

2 Lymphoma Canada. Chronic lymphocytic leukemia. www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed May 2020.

3 Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer- information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed May 2020.

4 Fischer K, et al. Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities. Presented at the 2019 American Society of Clinical Oncology Annual Meeting: June 4, 2019; Chicago.

5 N Engl J Med 2019;380:2225-36. DOI: 10.1056/NEJMoa1815281

AbbVie Announces New Formulary Listings for SKYRIZI® in the Treatment of Moderate to Severe Plaque Psoriasis

  • SKYRIZI® is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe 1
  • In clinical studies, SKYRIZI® significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).1
  • Non-Insured Health Benefits program lists SKYRIZI® on its formulary effective February 21,
  • Manitoba lists SKYRIZI® on its provincial formulary effective March 02,
  • SKYRIZI® is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the formularies of Alberta, Saskatchewan, Manitoba, Ontario, Quebec, Nova Scotia and the Non-Insured Health Benefits program.

 

MONTRÉAL, QC, March 11, 2020 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced today that SKYRIZI® (risankizumab) is now listed on the formularies of the Non-Insured Health Benefits program (NIHB) and the province of Manitoba for the treatment of moderate to severe plaque psoriasis. This announcement comes just three months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA), bringing a much-needed treatment to patients living with psoriasis.

 

Psoriasis is a chronic condition affecting 125 million people worldwide, including 1 million Canadians, and many patients despite treatment still do not reach their goals or lose treatment response over time.2-4 The most common form is plaque psoriasis, which affects approximately 90% of patients. 5

 

SKYRIZI® (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

 

“It’s been very rewarding to see my psoriasis patients on the biologic SKYRIZI® respond so favorably. In my patients, I witness both a durable skin response and an improvement in quality of life and well-being,” states Dr. Marni C. Wiseman MD FRCPC, Dermatologist from SKiNWISE DERMATOLOGY. “There currently is a need for treatments with longer dosing intervals for patients located in remote communities. I am so pleased that Manitobans and Canada’s Indigenous population will have better access to this treatment,” adds Dr.

Wiseman.

 

According to the 2016 census, Aboriginal peoples in Canada totaled 1,673,785 people, or 4.9% of the national population.6 Of these, 223,310 Aboriginal people live in Manitoba, making up 18.0% of that population.7

 

For the Non-Insured Health Benefits program (NIHB), SKYRIZI® is effectively listed on NIHB’s Limited Use

formulary as of February 21, 2020 and criteria details will be featured in their next bulletin update.

 

Information regarding the Manitoba provincial criteria may be found by consulting the following link:

 

 

About SKYRIZI®

SKYRIZI® is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23, a naturally occurring cytokine involved in inflammatory and immune responses.1 On April 17, 2019, SKYRIZI™ received a NOC from Health Canada for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3-month dosing in more than 2000 adult patients.1 Four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluated more than 2,000 patients with moderate to severe plaque psoriasis.4 Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to

Health Canada’s approval, showing the Canadian leadership in this clinical development program.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

 

Media:

Kim Hogan AbbVie Canada (514) 832-7288

kim.hogan@abbvie.com

 

References:

 

  1. SKYRIZI® (risankizumab) [Canadian Product Monograph]. AbbVie Corporation, April 17,
  2. International Federation of Psoriasis Associations. Accessed March 22, 2019. Available at: https://ifpa-pso.com/wp- content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf.
  3. Mroweitz, , et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  4. Levin, et Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.
  5. Canadian Dermatology Association – Psoriasis. Accessed on February 5,
  6. Statistics Canada, Aboriginal Population Profile, 2016 Census.
  7. Statistics Canada, Focus on Geography Series, Province of Manitoba, 2016 Census.

VENCLEXTA® with Rituximab, a Treatment for Patients With Chronic Lymphocytic Leukemia (CLL), now reimbursed in British Columbia

  • British Columbia is the second province to reimburse the combination
  • VENCLEXTA® + rituximab is a regimen that includes a targeted oral agent that should be continued for two years after initial five weeks ramp-up

 

Montreal (Quebec), February 26, 2020 –AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that VENCLEXTA® in combination with rituximab, a treatment for patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy, is now listed in British Columbia. VENCLEXTA in combination with rituximab is an effective treatment option that has the benefit of a finite treatment approach, meaning patients stop their therapy after two years of treatment.

 

“CLL is a chronic cancer, meaning that patients may eventually relapse. This is why it is important to have access to new innovative therapies and combinations. With VENCLEXTA in combination with rituximab, I am able to prescribe to my patients living with CLL an effective treatment with a clearly defined end-date, which is positive news for patients,” explains Dr. Alina Gerrie, MD MPH FRCPC, Assistant Professor, Hematology and Medical Oncology, University of British Columbia, Lymphoma Tumour Group, BC Cancer.

 

British Columbia Cancer in coordination with their Lymphoma Tumour Group has listed VENCLEXTA in combination with rituximab on formulary for the treatment of relapsed or refractory chronic lymphocytic leukemia in patients who have received at least one prior line of therapy.i

 

“The listing of VENCLEXTA plus rituximab in British Columbia is positive news for the people living with CLL,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are effective treatments available provides reassurance to people facing this uncertain journey.”

 

Furthermore, VENCLEXTA in combination with rituximab is listed as a Limited Use (LU) product on the Non-Insured Health Benefits (NIHB).ii

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodiii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iv

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases. VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

 

 

Canadians prescribed VENCLEXTA can be enrolled in AbbVie Care, AbbVie’s signature care program. The

program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

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Media Inquiries: Muriel Haraoui 514-717-3764

muriel.haraoui@abbvie.com

 

i BC Cancer. http://www.bccancer.bc.ca/chemotherapy-protocols-site/Documents/Lymphoma- Myeloma/ULYVENETOR_Protocol.pdf. Accessed February 2020.

ii Non-Insured Health Benefits: Drug Benefit List. https://www.sac- isc.gc.ca/eng/1572888328565/1572888420703#s4d. Accessed February 2020.

 

 

 

 

iii Lymphoma Canada. Chronic lymphocytic leukemia. www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed February 2020.

v VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision:

January 13, 2020. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed

February 2020.

AbbVie’s SKYRIZI™ Now Listed on the Nova Scotia Formulary for the Treatment of Moderate to Severe Plaque Psoriasis

  • SKYRIZI™ is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe 1
  • In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and

maintained clearance at one year (52 weeks).1

  • SKYRIZI™ is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the provincial formularies of Ontario, Alberta, Saskatchewan, Quebec and Nova
  • Nova Scotia lists SKYRIZI™ on its provincial formulary effective February 06,

 

MONTRÉAL, QC, February 13, 2020 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced today that Nova Scotia has listed SKYRIZI™ (risankizumab) on its provincial formulary for the treatment of moderate to severe plaque psoriasis. This announcement comes just two months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA). Nova Scotia joins Ontario, Alberta, Saskatchewan and Quebec in bringing a much-needed treatment to patients living with psoriasis.

 

SKYRIZI™ (risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

 

“Risankizumab demonstrated high levels of skin clearance and persistence of effect. I am delighted that Dermatologists in Nova Scotia and our patients have a new option that can help patients achieve and maintain a high level of treatment response”, states Dr. Richard Langley MD, Professor and Director of Research in the Division of Dermatology at Dalhousie University and a principal investigator for the pivotal trials and senior author of the IMMhance study.

 

Psoriasis is a chronic condition affecting 125 million people worldwide, including 1 million Canadians, and many patients despite treatment still do not reach their goals or lose treatment response over time.2-4 The most common form is plaque psoriasis, which affects approximately 90% of patients. 5 Of these patients, 28% or approximately 325,000 Canadians are considered moderate to severe.6

 

“At CAPP we are always excited to hear of new treatment options being made available to psoriasis patients. We know that, while being a physical burden to patients, plaque psoriasis also has a huge emotional burden on patients. When patients can access more effective treatments and experience desired skin clearance, this gives them not just physical comfort, but also relief from the emotional burden of living with such a visible condition,” explains Rachael Manion, Executive Director, Canadian Association of Psoriasis Patients.

 

Information regarding the provincial criteria may be found by consulting the following link:

 

About SKYRIZI™

SKYRIZI™ is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23, a naturally occurring cytokine involved in inflammatory and immune responses.1 On April 17, 2019, SKYRIZI™ received a NOC from Health Canada for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3-month dosing in more than 2000 adult patients.1 Four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluated more than 2,000 patients with moderate to severe plaque psoriasis.4 Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program.

SKYRIZI™ is the only IL-23 inhibitor to arrive to a positive conclusion with the pCPA and is currently listed on the provincial formularies of Ontario, Alberta, Saskatchewan, Quebec, and Nova Scotia.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on

our Facebook or LinkedIn page.

-30-

 

Media:

Kim Hogan AbbVie Canada (514) 832-7288

kim.hogan@abbvie.com

 

 

References:

 

  1. SKYRIZI™ (risankizumab) [Canadian Product Monograph]. AbbVie Corporation, April 17,
  2. International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp- content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22,
  3. Mroweitz, , et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  4. Levin, et Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.
  5. Canadian Dermatology Association – Psoriasis. Accessed on February 5, 2020. Available at: https://dermatology.ca/public- patients/skin/psoriasis/
  6. Petrella RJ, Gregory V, Luciani L, Barbeau M . Characteristics of chronic plaque psoriasis in Canada: a retrospective database (PSS7) Poster presented at ISPOR 19th Annual International Meeting, Montréal, QC, Canada, May 2014. Accessed on February 5, 2020. Available at:

AbbVie’s SKYRIZI™ Now Publicly Reimbursed in Ontario, Alberta, Saskatchewan and Quebec for the Treatment of Moderate to Severe Plaque Psoriasis

  • SKYRIZI™ is an interleukin-23 (IL-23) inhibitor used for the treatment of moderate to severe 1
  • In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and

maintained clearance at one year (52 weeks).1

  • SKYRIZI™ is the only IL-23 inhibitor to arrive at a positive conclusion with the pCPA and is currently listed on the provincial formularies of Ontario, Alberta, Saskatchewan and
  • Ontario lists SKYRIZI™ on its provincial formulary effective January 31,
  • Alberta lists SKYRIZI™ on its provincial formulary effective February 01,
  • Saskatchewan lists SKYRIZI™ on its provincial formulary effective February 01,
  • Quebec lists SKYRIZI™ on its provincial formulary effective February 05,

 

MONTRÉAL, QC, February 06, 2020 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced today that Ontario, Alberta, Saskatchewan and Quebec have listed SKYRIZI™ (risankizumab) on their respective provincial formularies for the treatment of moderate to severe plaque psoriasis. This announcement comes just two months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) – bringing a much-needed treatment to patients living with psoriasis.

 

“I have been working with SKYRIZI™ for the past four years as I have been involved in the clinical trials. A cure does not exist for psoriasis; however, this biologic therapy targets a cytokine, IL-23, that regulates psoriasis. I have seen very positive, long-lasting results, including improvements to the patient’s overall health and well-being. I am excited that more people in Ontario will now have access to this new

targeted innovative therapy,” states Dr. Melinda Gooderham, a dermatologist from the SKiN Centre for Dermatology in Peterborough, Ontario.

 

Psoriasis is a chronic condition affecting 125 million people worldwide, including 1 million Canadians, and many patients despite treatment still do not reach their goals or lose treatment response over time.2-4 The most common form is plaque psoriasis, which affects approximately 90% of patients. 5

 

“Psoriasis severely affects an individual’s quality of life. I am so pleased that my patients suffering with moderate to severe psoriasis will now be able to access SKYRIZI™ through Alberta’s publicly funded medication insurance program,” explains Dr. Kirk Barber, Chief Dermatologist, Calgary Treatment & Research. “In my clinical practice it has been a significant advancement in treatment especially due to its convenient dosing and predictable complete clearance – which is long lasting.”

 

Psoriasis is a significant problem in primary care, affecting 3.1% of the Canadian population.6 Of these patients, 28% or approximately 325,000 Canadians are considered moderate to severe.7

 

 

Information regarding specific provincial criteria may be found by consulting the links below:

 

 

SKYRIZI™ is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

 

“Our patients suffering from psoriasis now have access to highly targeted and effective treatment

options. Our knowledge about the disease’s immunopathology keeps improving. So is treatment practicality, as some treatments have longer dosage intervals and can be administered only once every 3 months, for example. We are now in a position where we can virtually control the disease in most psoriasis patients,” says Dr. Yves Poulin, a dermatologist and dermatology professor at Université Laval. “New treatment options like risankizumab are groundbreaking for our patients and for our ability to provide them with adequate care, and consequently improve their quality of life. And they deserve it, given the destructive impact the disease has on their life.”

 

About SKYRIZI™

SKYRIZI™ is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL- 23, a naturally occurring cytokine involved in inflammatory and immune responses.1 On April 17, 2019, SKYRIZI™ received a NOC from Health Canada for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3-month dosing in more than 2000 adult patients.1 Four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluated more than 2,000 patients with moderate to severe plaque psoriasis.4 Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program. SKYRIZI™ is the only IL-23 inhibitor to arrive to a positive conclusion with the pCPA and is currently listed on the provincial formularies of Ontario, Alberta, Saskatchewan and Quebec.

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance

 

health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

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Media:

Kim Hogan AbbVie Canada (514) 832-7288

kim.hogan@abbvie.com

 

 

References:

 

  1. SKYRIZI™ (risankizumab) [Canadian Product Monograph]. AbbVie Corporation, April 17,
  2. International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp- content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019.
  3. Mroweitz, , et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  4. Levin, et al. Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 3109/09546634.2013.826341.
  5. Canadian Dermatology Association – Psoriasis. Accessed on February 5, 2020. Available at: https://dermatology.ca/public-patients/skin/psoriasis/
  6. Papp K, Valenzuela F, Poulin Y, Bernstein G, Wasel N. Epidemiology of moderate-to-severe plaque psoriasis in a Canadian surveyed J Cutan Med Surg. 2010;14(4):167-174.
  7. Petrella RJ, Gregory V, Luciani L, Barbeau M . Characteristics of chronic plaque psoriasis in Canada: a retrospective database study. (PSS7) Poster presented at ISPOR 19th Annual International Meeting, Montréal, QC, Canada, May Accessed on February 5, 2020. Available at:

AbbVie’s MAVIRET® now listed on the Newfoundland and Labrador formulary

  • MAVIRET® is an 8-week, pan-genotypic treatment for adults and adolescent patients 12 to 18 years of age with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to *1
  • MAVIRET is approved for use in patients across all stages of chronic kidney disease (CKD).
  • MAVIRET is now available and reimbursed across

 

MONTREAL (Quebec), January 14, 2020 – AbbVie (NYSE: ABBV), a global, research and development- based biopharmaceutical company announced today that MAVIRET® (glecaprevir/pibrentasvir tablets) is now listed on the Newfoundland and Labrador Formulary. MAVIRET is a once-daily ribavirin-free treatment for adults and adolescent patients 12 to 18 years of age with chronic hepatitis C virus (HCV) infection across all major HCV genotypes (GT1-6).2 It is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

“As a nurse practitioner, I see firsthand the devastating effects hepatitis C has in our communities and on those living with this disease. But we can change the narrative because we have all the right tools to eliminate this disease. We have the understanding, knowledge, resources and treatments like MAVIRET, to educate and treat everyone living with hepatitis C,” says Kimberley A. Burt RN, BN, NP, Provincial

Immunodeficiency Nurse Practitioner, Eastern Health, St. John’s, Newfoundland.

 

MAVIRET is listed on the Newfoundland and Labrador Formulary for treatment-naive or treatment- experienced adult patients with chronic hepatitis C genotype 1,2,3,4,5 or 6 infection.3

 

“Our vision is to work together to create a province without hepatitis C. To achieve this goal, we have to continue to raise awareness, educate, support people living with and/or affected by hepatitis C, as well as advocate for change,” explains Gerard Yetman, Executive Director, AIDS Committee of Newfoundland and Labrador. “We strongly believe that the newer treatments, such as MAVIRET, will have a positive impact and help us fulfill our mandate to eliminate hepatitis C from our province.”

 

MAVIRET’s efficacy and safety were evaluated in nine phase II-III clinical trials, in over 2300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.4 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.5 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

 

About MAVIRET®

MAVIRET is approved in Canada for the treatment of chronic hepatitis C virus (HCV) in adults and adolescent patients 12 to 18 years of age across all major genotypes (GT1-6).6 MAVIRET is a pan- genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A protein inhibitor. MAVIRET is taken once daily as three oral tablets.6

 

MAVIRET is an 8-week, pan-genotypic treatment that makes a virologic cure** possible in patients without cirrhosis who are new to treatment.*1 These patients represent the majority of people infected with HCV. MAVIRET is also approved in patients with specific treatment challenges, including those with compensated cirrhosis, who are carriers of one of the major genotypes, and those who previously had limited treatment options, such as patients with severe CKD, post-liver and post-renal transplant recipients*** and those patients with genotype 3 HCV infection.6 MAVIRET is approved for use in patients across all stages of CKD.6

 

Glecaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) to develop HCV protease inhibitors and therapeutic regimens that include protease inhibitors.

 

* Patients without cirrhosis and new to treatment with direct-acting antivirals (DDAs), (i.e., either treatment-naive or did not respond to previous interferon-based treatments (pegylated interferon [peg IFN] +/- ribavirin or sofosbuvirribavirin +/-peg IFN).

** Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT1-6 treatment-naive or HCV GT-1, -2, -4, -5 or -6 PRS (IFN or peg IFN, ribavirin and/or sofosbuvir)-treatment experienced. A 16-week treatment duration should be considered in transplant patients who are HCV GT-1 NS5A inhibitor experienced (but NS3/4A inhibitor-naive) or HCV GT-3 PRS- treatment experienced.

 

About AbbVie Care

Canadians prescribed MAVIRET can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, personalized education and ongoing disease management support throughout the treatment.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to

developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

-30-

Media:

Kim Hogan AbbVie Canada

kim.hogan@abbvie.com

514-243-8186

 

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final. www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed January 2020.

3 Newfoundland and Labrador. Department of Health and Community Services. https://nlpdp.bell.ca/default.aspx. Accessed June 2019.

4 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed January 2020. 5 The Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/. Accessed January 2020.

6 AbbVie Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: June 25, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.pdf. Accessed January 2020.

AbbVie Receives Health Canada Approval of RINVOQ® (upadacitinib), an Oral Medication for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

  • Approval supported by efficacy and safety data from the pivotal Phase 3 SELECT rheumatoid arthritis (RA) program, one of the largest registrational Phase 3 programs in RA with approximately 4,400 patients evaluated across five studies1-5
  • About one in every 100 adult Canadians, or approximately 300,000 people, are living with rheumatoid arthritis, the majority of whom don’t achieve remission6,7

 

MONTREAL, QC, January 7, 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX). RINVOQ is a

15 mg, once-daily oral Janus kinase (JAK) inhibitor and may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).

 

“While there has been tremendous progress in the treatment of rheumatoid arthritis over the past two decades, too many patients still don’t reach remission and continue to suffer from pain, fatigue and morning joint stiffness,” said Dr. Edward Keystone, MD, FRCPC, Professor of Medicine, University of Toronto. “RINVOQ had one of the largest Phase 3 clinical trial programs in rheumatoid arthritis, and this medicine has the potential to significantly improve signs and symptoms of the disease.”

 

Gaétane Lepire, who lives with rheumatoid arthritis, explained the impact the disease has had on her life: “It affected me because I had pain in my feet, my knees, my back and my hands 24 hours a day, seven days a week. I tried to function as if everything were okay, but it affected me, and sometimes I couldn’t do the things I was used to doing. I had trouble getting out of bed, going up and down three steps, getting in and out of the car, etc.”

 

“Rheumatoid arthritis affects 1 in 100 Canadians and causes disability in many. RINVOQ has

 

 

 

 

 

 

 

 

Designed to help accommodate the physical limitations of people living with RA, the packaging for RINVOQ includes a bottle cap with a wide, easy-to-grip texture and an embedded tool that punctures the foil liner to simplify medication access.

 

“For many people living with arthritis, the act of opening a medicine bottle or picking up a tablet can be extremely difficult, and AbbVie designed the RINVOQ tablet, bottle and cap with this in mind,” said Ken Gagnon, Vice President, Corporate Partnerships, The Arthritis Society. “We are pleased to give this medication our Ease of Use designation, which recognizes products that are designed to make life easier for people with arthritis.”

 

“AbbVie has been dedicated to discovering and delivering innovative therapies for people living with rheumatic diseases for nearly two decades,” added Stéphane Lassignardie, Vice President and General Manager, AbbVie Canada. “We are proud to expand our portfolio of treatment options for Canadians living with RA, particularly by offering people the convenience of a medication taken orally, in a once-daily extended-release tablet.”

 

About the Phase 3 SELECT Rheumatoid Arthritis Program

 

The Health Canada approval of RINVOQ was supported by data from the global Phase 3 SELECT rheumatoid arthritis program, which evaluated nearly 4,400 patients with moderate to severe active rheumatoid arthritis in five pivotal studies.1-5

 

The studies include assessments of efficacy, safety and tolerability across a variety of patients, including those who were methotrexate naïve or had an inadequate response to methotrexate (MTX), patients who were intolerant to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), and patients who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs (DMARDS).1-5

 

  • SELECT-EARLY was a 48-week trial in 947 patients with moderately to severely active rheumatoid arthritis who were naïve to
  • SELECT-MONOTHERAPY was a 14-week monotherapy trial in 648 patients with moderately to severely active rheumatoid arthritis who had an inadequate response to
  • SELECT-NEXT was a 12-week trial in 661 patients with moderately to severely active rheumatoid arthritis who had an inadequate response to conventional synthetic disease modifying anti-rheumatic
  • SELECT-COMPARE was a 48-week trial in 1,629 patients with moderately to severely active rheumatoid arthritis who had an inadequate response to
  • SELECT-BEYOND was a 12-week trial in 499 patients with moderately to severely active rheumatoid arthritis who had an inadequate response or intolerance to biologic disease-modifying anti-rheumatic

 

 

 

 

 

 

 

 

About RINVOQ® (upadacitinib)8

RINVOQ® (upadacitinib) is a 15 mg, once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.

 

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ may be used as monotherapy or in combination with other nonbiologic DMARDs.

 

For important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.

 

About AbbVie Care

Canadians prescribed RINVOQ will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services such as reimbursement and financial support, pharmacy services, lab work reminders and coordination, as well as personalized education and ongoing disease management support from a dedicated AbbVie Care nurse, throughout the treatment journey.

For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbviecanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

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References:

 

1 Genovese MC, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140- 6736(18)31116-4. Epub 2018 Jun 13.

 

2 Smolen JS, et al. Upadacitinib as monotherapy in patients with active rheumatoid arthritis and inadequate response to methotrexate (SELECT-MONOTHERAPY): a randomised, placebo-controlled, double-blind phase 3 study. Lancet. 2019. May 23. doi: 10.1016/S0140-6736(19)30419-2. Epub 2019

May 23.

 

3 Fleischmann R, et al. Upadacitinib versus placebo or adalimumab in rheumatoid arthritis and an inadequate response to methotrexate: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis and Rheumatology. 2019. Jul 9. doi: 10.1002/art.41032.

 

4 van Vollenhoven R, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891.

 

5 Cohen S, et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.

 

6 Arthritis Society, What is rheumatoid arthritis. Available at: https://arthritis.ca/about-arthritis/arthritis- types-(a-z)/types/rheumatoid-arthritis, Accessed December 11, 2019.

 

7 Ajeganova S. and Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017 Oct;9(10):249-262. doi: 10.1177/1759720X17720366.

 

8 RINVOQ Product Monograph. Available at:

http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/RINVOQ_PM.pdf. Accessed January 6, 2020.

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia (CLL)

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA)i, Quebec is the first province to reimburse the combination
  • VENCLEXTA® + rituximab is a regimen that includes a targeted oral agent that should be continued for two years after initial five weeks ramp-up

 

Montreal (Quebec), December 18, 2019 –AbbVie (NYSE: ABBV), a global research and development- based biopharmaceutical company, today announced that an agreement has been reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA® in combination with rituximab, a treatment for patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy.

 

“VENCLEXTA in combination with rituximab is an effective treatment option. VENCLEXTA plus rituximab also have the benefit of a finite treatment approach, meaning patients can stop their therapy after two years of treatment and continue to benefit,” said Dr. Sarit Assouline MD, MSc, FRCPC, Senior Investigator, Lady Davis Institute, Associate Professor, Department of Oncology, McGill University. “It’s great news that patients in Quebec will now have access to this treatment.”

 

On the Régie de l’assurance maladie du Québec’s Liste des médicaments, VENCLEXTA is listed in combination with rituximab, for the treatment of relapsed or refractory chronic lymphocytic leukemia in patients who have received at least one prior therapy.ii For full criteria, consult the list of medications in effect.

 

“The pCPA agreement for VENCLEXTA plus rituximab is positive news for Canadians living with CLL,” says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. “Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are effective treatments available provides reassurance to people facing this uncertain journey.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodiii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iv

 

“We are thrilled with the positive outcome of our discussions with the pan-Canadian Pharmaceutical Alliance and that Quebec is the first province to list VENCLEXTA in combination with rituximab. We are looking forward to making this treatment available to all Canadians across the country,” says Stéphane Lassignardie, Vice-President and General Manager, Abbvie Canada. “With a strong commitment to developing innovative therapies for patients and contributing to longer-term healthcare sustainability, AbbVie is committed to providing solutions that bring significant clinical and economic value to patients, healthcare practitioners and our healthcare system.”

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases. VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

 

About the MURANO Study

A total of 389 patients with relapse / refractory (R/R) CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized (1:1) MURANO study (NCT02005471). The study was designed to evaluate the efficacy and safety of VENCLEXTA in combination with rituximab (194 patients) compared with bendamustine in combination with rituximab (195 patients). The median age of patients in the trial was 65 years (range 22-85).v The MURANO study is unique in its design with the intention for patients to stop therapy after 24 months.

 

About AbbVie Care

Canadians prescribed VENCLEXTA can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

i Pan-Canadian Pharmaceutical Alliance: Completed Negotiations. As of October 31, 2019. https://www.canadaspremiers.ca/wp-content/uploads/2019/11/PCPA_completed_negotiations_2019-10.pdf. Accessed December 2019.

ii Régie de l’assurance maladie du Québec. Liste des médicaments. http://www.ramq.gouv.qc.ca/fr/publications/citoyens/publications-legales/Pages/liste-medicaments.aspx. Accessed December 2019.

iii Lymphoma Canada. Chronic lymphocytic leukemia. www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed December 2019.

iv Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer- information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed December 2019.

v VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: December 2, 2019. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed

December 2019.

AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis

  • Psoriasis is a chronic condition affecting 125 million people worldwide and many patients despite treatment still do not reach their goals or lose treatment response over 1-3
  • SKYRIZI™ is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit.4
  • On April 17, 2019, SKYRIZI™ received a NOC from Health Canada for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy, based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3-month dosing in more than 2000 adult 4
  • In May 2019, SKYRIZI™ received positive reimbursement recommendations from the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d’excellence en santé et services sociaux (INESSS).
  • SKYRIZI™ is the first IL-23 inhibitor to arrive to a positive conclusion with the

 

MONTREAL, QC, December 6, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company, announced an agreement was reached with the pan-Canadian Pharmaceutical Alliance (pCPA) regarding SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

 

“Although the introduction of biologics has improved treatment outcomes, many patients continue to live with their needs unmet. Patients strive for therapies that provide predictable and durable full skin clearance with convenient dosing. Ultimately, they want a therapy that improves their quality of life’’, Dr. Kim Papp, Probity Medical Research Inc. ‘’It is great news to know that more Canadians will have access to a new treatment option.”

 

SKYRIZI™ received Health Canada approval in April 2019 based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.4 SKYRIZI™ is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

 

Canadians living with moderate to severe plaque psoriasis were well represented in all four of the

pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program. In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).4

 

 

“We are committed to continuing to improve the lives of those living with psoriasis where there is still much to be done,” explains Stéphane Lassignardie, Vice-President and General Manager, AbbVie Canada. We are extremely proud that SKYRIZI™ is the first IL-23 inhibitor to reach an agreement with the pCPA. This is a great step forward for Canadians to obtain access to this innovative therapy.”

 

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

 

Media:

Kim Hogan AbbVie Canada (514) 832-7288

kim.hogan@abbvie.com

 

 

References:

 

  1. International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp- content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22,
  2. Mroweitz, , et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  3. Levin, et al. Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 3109/09546634.2013.826341.
  4. SKYRIZI™ (risankizumab) [Canadian Product Monograph]. AbbVie Corporation,