Tag: $ABBV

MAVIRET® (glecaprevir/pibrentasvir) Approved by Health Canada for Pediatric Patients with Chronic Hepatitis C

• MAVIRET can now be used as an 8-week, once-daily paediatric granule formulation option in treatment-naïve, without cirrhosis or with compensated cirrhosis, chronic Hepatitis C (HCV) paediatric patients aged 3 to <12 years with genotype (GT)1-6, weighing at least 12kg to less than 45kg
• Health Canada’s decision makes MAVIRET the first pan-genotypic treatment option for treatment-naïve, compensated cirrhotic, chronic HCV patients as young as 3 years of age and weighing 12kg or more
• This approval is supported by 98.4 per cent cure* rate across this group of patients who received the approved paediatric granule formulation

Montreal, QC, June 22, 2022 – AbbVie (NYSE: ABBV) announced today that Health Canada has approved a change in the marketing authorization for MAVIRET® (glecaprevir/pibrentasvir) to include its use for the treatment in paediatric patients 3 to 12 years old, weighing at least 12kg to less than 45kg.1 MAVIRET is now approved as an 8-week, pan-genotypic (GT1-6) treatment for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older.1** “There is an estimated 250,000 people living in Canada with chronic hepatitis C including young children who I have witnessed first-hand at SickKids in need of treatment options,” said Dr. Simon Ling, MBChB, MRCP(UK), Division of Gastroenterology, Hepatology and Nutrition, SickKids Toronto. “The approval of MAVIRET® as a paediatric indication is a necessary step that will add a beneficial therapeutic option to treat HCV infection in children.” The label extension is supported by data from the phase 2/3, non-randomized, open-label, multicenter DORA Part 2 study evaluating the safety and efficacy of weight-based dosing of glecaprevir/pibrentasvir (G/P) granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years with chronic HCV infection.1 Patients received a paediatric formulation of glecaprevir (GLE)/pibrentasvir (PIB), comprised of film-coated granules of GLE and PIB, in a sachet mixed together in a small amount of soft food for once-daily oral administration. The mixture of food and granules should be swallowed immediately; the granules should not be crushed or chewed.1 “With Canada’s commitment to eliminating viral hepatitis as a public health threat by 2030, the approval of MAVIRET ® for paediatric patients is a positive advancement in reaching our goals,” said Jennifer van Gennip, Executive Director, Action Hepatitis Canada. “Now with access to treatment of viral hepatitis amongst children, one more barrier to elimination is removed.” In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62)1 . No subject taking the final recommended dose experienced virologic failure1 . The adverse reactions observed in patients 3 less than 12 years of age were consistent with those observed in clinical trials of MAVIRET in adults with the exception of vomiting (occurring at approximately 8%), rash, and abdominal pain upper (each occurring at approximately 4%) which were observed more frequently than in adults.1 “MAVIRET has had a significant impact on the lives of people affected by chronic HCV, and we are pleased that pediatric patients are now also able to benefit from this treatment option,” said Tracey Ramsay, Vice-president and General Manager, AbbVie Canada. “We are committed to helping achieve the World Health Organization’s 2030 goal of HCV elimination and we believe Health Canada’s expanded approval for MAVIRET will help Canadians to get one step closer.” About the DORA part 2 Study2 The efficacy, safety and pharmacokinetics of G/P in children 3 years to less than 18 years old was demonstrated in an open-label study which was comprised of two parts, DORA Part 13 and Part 22 . DORA Part 2 evaluated the safety and efficacy of weight-based dosing of G/P granules for 8, 12 or 16 weeks in 80 children aged 3 years to less than 12 years. 18 subjects received the initial lower dose, and 62 subjects received the final recommended dose. The median age was 7 years (range: 3 to 11); 73% had HCV genotype 1, 3% had genotype 2, 23% had HCV genotype 3, 3% had HCV genotype 4; 55% were female; 4% were Black; 97.5% were HCV TN; 2.5% were treatment-experienced to interferon; 1% had HIV-coinfection; none had cirrhosis; the mean weight was 25 kg (range: 13 to 44). In DORA Part 2, the overall SVR12 rate for the subjects who received the final recommended dose was 98.4% (61/62). No subject taking the final recommended dose experienced virologic failure. One 9-year-old child with HCV GT3b infection, who had received the initial lower dose, experienced virologic failure. The child had K30R and V31M at baseline and treatment-emergent Y93H at relapse in NS5A; baseline or treatmentemergent substitutions were not detected in NS3. The pattern of adverse reactions observed was comparable with that observed in clinical studies of G/P film-coated tablets in adolescents and adults. About MAVIRET™ (glecaprevir/pibrentasvir)1,2 MAVIRET® is approved by Health Canada for the treatment of chronic hepatitis C virus (HCV) infection in adults and children 3 years and older across all major genotypes (GT1-6). MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets. The new paediatric formulation consists of MAVIRET coated granules in sachet. Each sachet contains 50mg of glecaprevir and 20mg of pibrentasvir. The recommended dosage in number of sachets is based on body weight for children1 . MAVIRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are new to treatment**. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney1 disease (CKD). MAVIRET is a pangenotypic treatment approved for use in patients across all stages of CKD. Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B).1 For important safety information, please consult the MAVIRET Product Monograph at www.abbvie.ca. About Hepatitis C An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 40% 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 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.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn. -30- Media: Muriel Haraoui AbbVie Canada 514-717-3764 muriel.haraoui@abbvie.com *Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C. **The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients with or without cirrhosis. 1AbbVie Canada. Maviret Product Monograph. Retrieved https://www.abbvie.ca/content/dam/abbviedotcom/ca/en/documents/products/MAVIRET_PM_EN.pdf. April 2022. 2 Jonas MM et al. Pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir in children with chronic hepatitis C virus: part 2 of the DORA study. J Hepatol (2021) 3 Jonas, MM et al. Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Virus: Part 1 of the DORA Study. J Hepatol (2020) 4Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf Accessed April 2022. 5Canadian Liver Foundation. How you advocate. https://www.liver.ca/how-you-help/advocate/ Accessed April 2022.

Health Canada Approves VRAYLAR® (cariprazine) for the Treatment of Bipolar l Disorder and Schizophrenia in Adults

VRAYLAR^® is a new atypical antipsychotic medication with partial agonist activity at central dopamine D₃ receptors in addition to targeted activity at D₂ and serotonin 5-HT_1A and 5-HT_2A receptors. ¹

MONTREAL, April 27, 2022 /CNW Telbec/ – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that Health Canada has approved VRAYLAR^® (cariprazine) as monotherapy for the acute management of manic, mixed, and depressive episodes associated with bipolar l disorder in adults, as well as the treatment of schizophrenia in adults.¹

Bipolar I disorder is a mental illness characterized by extreme mood swings that can impact an individuals’ ability to think, behave and function.² It can consist of three states which includes manic, depressive, and mixed episodes.³ While the causes of bipolar I disorder are unknown, biological factors can play a role and can be difficult to diagnose due to the wide range of symptoms.³

Schizophrenia is a severe mental illness that can also impact a person’s ability to function, and often presents symptoms that can change over time. Symptoms can include hallucinations, disorganized speech, social withdrawal, and catatonic behaviour.³

“I have seen firsthand what impact bipolar l disorder and schizophrenia can have on a person’s life. These are complex illnesses that can be difficult to treat and manage. It is important that we have additional treatment options available for persons affected,” says Dr. Roger S. McIntyre, M.D., FRCPC, Professor of Psychiatry and Pharmacology, University of Toronto. “As a healthcare professional, I am pleased to hear that this treatment is now available for Canadians who live with bipolar l disorder or schizophrenia.”

It’s estimated 2.2% of Canadians will experience bipolar l disorder in their lifetime and can impact both men and women equally,⁴ while an estimated 300,000 Canadians are impacted by schizophrenia.³ Stigma remains prevalent in both disorders, with patients often experiencing discrimination and difficulty in accessing resources and treatment.⁵

“We know that living with bipolar l disorder can present various challenges impacting the daily lives of patients and their families,” Dave Gallson, National Executive Director, Mood Disorders Society of Canada. “The Mood Disorders Society of Canada thanks Health Canada for the approval of VRAYLAR^®, which will support those in the community in managing this mental illness. It is encouraging to see new treatment options for people with bipolar I disorder.”

“We are pleased to see the progress in new treatments to support Canadians living with schizophrenia,” says Chris Summerville, CEO of the Schizophrenia Society of Canada. “Patients are looking for convenient and safe treatments to support their health and recovery. VRAYLAR^® will offer new hope for many Canadians and help minimize the burdens associated with schizophrenia to support patients and their caregivers.”

“Mental illness affects many Canadians either through personal experience, or that of a family member, friend, or colleague,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada. “The approval of VRAYLAR^® is an important milestone that will support patients suffering from bipolar I disorder and schizophrenia. At AbbVie, we are committed to providing new treatment options to enhance patient care and support the unmet needs of mental illness community.”

About VRAYLAR^® (cariprazine) ¹
VRAYLAR^® is an oral, once daily atypical antipsychotic approved as monotherapy for the acute management of manic, mixed, and depressive episodes associated with bipolar l disorder in adults, as well as the treatment of schizophrenia in adults.

The mechanism of action of cariprazine in schizophrenia and bipolar I disorder is unknown. However, the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at central dopamine D₃, D₂ and serotonin 5-HT_1A receptors and antagonist activity at 5-HT_2A receptors. Cariprazine forms two major metabolites, desmethyl cariprazine (DCAR) and didesmethyl cariprazine (DDCAR), that have in vitro receptor binding and functional activity profiles similar to the parent drug.

VRAYLAR^® is contraindicated in patients who are hypersensitive to cariprazine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. VRAYLAR^® is also contraindicated with concomitant use with strong and moderate CYP3A4 inhibitors / inducers. Due to the slow elimination of cariprazine and its metabolites, treatment with strong and moderate CYP3A4 inhibitors must be initiated at least 2 weeks after VRAYLAR discontinuation.

VRAYLAR is being developed jointly by AbbVie and Gedeon Richter Plc, with AbbVie responsible for commercialization in the U.S., Canada, Japan, Taiwan and certain Latin American countries (including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru and Venezuela).

Please consult the VRAYLAR^® Product Monograph at www.allergan.ca.

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.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

1 VRAYLAR Product Monograph. Allergan Inc. April 22nd 2022.

2 CAMH. Bipolar Disorder. Retrieved from https://www.camh.ca/en/health-info/mental-illness-and-addiction-index/bipolar-disorder. Accessed March 2022.

3 Schizophrenia Society of Canada. Learn more about Schizophrenia. Retrieved from https://schizophrenia.ca/learn-more-about-schizophrenia/ . Accessed March 2022.

4 Canadian Psychological Association. “Psychology Works” Fact Sheet: Bipolar Disorder. Retrieved from https://cpa.ca/psychology-works-fact-sheet-bipolar-disorder/. Accessed March 2022.

5 CAMH. Addressing Stigma. Retrieved from https://www.camh.ca/en/driving-change/addressing-stigma. Accessed March 2022.

SOURCE AbbVie Canada

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2022/27/c4557.html

AbbVie Expands Immunology Portfolio in Canada as Health Canada approves SKYRIZI® (risankizumab) for the Treatment of Adults with Active Psoriatic Arthritis

• Approval supported by data from two Phase 3 studies evaluating SKYRIZI in psoriatic arthritis patients, KEEPsAKE-1 and KEEPsAKE-2^1,2
• Psoriatic arthritis is a systemic inflammatory disease that impacts the skin and joints, affecting approximately 30 percent of patients with psoriasis^3,4,5

MONTREAL, March 17, 2022 /CNW/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced Health Canada has approved SKYRIZI^® (risankizumab), for the treatment of adult patients with active psoriatic arthritis. In PsA, SKYRIZI can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate).

“SKYRIZI receiving Notice of Compliance for the treatment of active psoriatic arthritis gives additional hope to patients. Results from the Phase 3 clinical trial program indicate improvement in the signs and symptoms associated with this disease,” said Dr. Kim Alexander Papp, MD, PhD, FRCPC, FAAD, Probity Medical Research.

“At AbbVie, we strive to transform the standard of care for immunocompromised people, and we are excited with Health Canada’s approval of SKYRIZI for the treatment of adults with active psoriatic arthritis,” said Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

This is the second indication for SKYRIZI in Canada. In April 2019, Health Canada approved SKYRIZI for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.⁶

About Psoriatic Arthritis
Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and the presence of psoriatic lesions.^4,5

About KEEPsAKE-1 and KEEPsAKE-2^1,2
KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARD.

About SKYRIZI^® (risankizumab)⁶
Risankizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits IL-23, a cytokine involved in inflammatory and immune responses.

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

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.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

1 Kristensen, L.E., et al. Efficacy and Safety of Risankizumab in Patients With Active Psoriatic Arthritis After Inadequate Response or Intolerance to DMARDs: 24-Week Results From the Phase 3, Randomized, Double-Blind KEEPsAKE 1 Trial.

2. Östör, A., et al. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis, Including Patients With Inadequate Response or Intolerance to Biologic Therapies: 24-Week Results From the Phase 3, Randomized, Double-blind, KEEPsAKE 2 Trial.

3. Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on October 25, 2021.

4. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003

5. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on October 25, 2021

6. AbbVie Product Monograph. March 2022. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/SKYRIZI_PM_EN.pdf

SOURCE AbbVie Canada

Focusing on the silent thief of sight during World Glaucoma Week

New survey reveals 45% of Canadians living with glaucoma had no prior knowledge of their disease before diagnosis

MONTREAL, March 9, 2022 /CNW/ – It’s estimated 728,000 Canadians are living with glaucoma.¹ The estimate for people living with vision loss in Canada is likely greater.² Known as the ‘silent thief of sight’, glaucoma is an eye disease where increased intraocular pressure can damage the optic nerve and lead to permanent vision loss.³ Vison loss symptoms can be difficult to recognize. If glaucoma is diagnosed at an early stage, treatment can usually control or prevent further vision loss.⁴ If left untreated, permanent vision loss of some form is likely to occur.⁵

This week marks World Glaucoma Week – a global initiative that takes place between March 6-12, to increase disease awareness and encourage those at risk to seek regular eye exams.

A national survey, conducted by Leger Research, engaged 150 Canadians living with glaucoma, to understand challenges, needs and insights surrounding their glaucoma experience.

Survey findings revealed⁶ :

• 69% of respondents don’t know what type of glaucoma they have
• 22% of respondents experienced some vision loss before being diagnosed with glaucoma
• The average age of glaucoma diagnosis is 51. Regionally, Quebecers were significantly more likely to be diagnosed between age 26-41 and between 42-57 and less likely to have had a diagnosis at age 65+.
• 59% of glaucoma patients say at least one of their family members has also been examined to check if they have glaucoma

The survey also revealed that 65% of respondents rely on their doctor’s office for new resources and information to support their understanding of glaucoma, and 39% of respondents search online. While there is no cure for glaucoma, access to resources and information can help enhance glaucoma management and improve patient outcomes.

Canadians are encouraged to learn about the effects of glaucoma, get their eyes checked for glaucoma to support early diagnosis and access resources such as Fighting Blindness Canada website (FightingBlindness.ca).

For more information on World Glaucoma Week visit https://www.worldglaucomaweek.org/

About Survey
Commissioned by Allergan, an AbbVie Company, the survey was conducted using Leger’s online panel between February 24-26, 2022, with 150 Canadians who have been diagnosed with glaucoma. The estimated margin of error is ±8.0 %, 19 times out of 20.

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.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

1 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/ Accessed March 2022. 2 The cost of vision loss and blindness in Canada. Canadian Council of the Blind. May 2021. Retrieved from https://www.fightingblindness.ca/wp-content/uploads/2021/12/Deloitte-Cost-of-vision-loss-and-blindness-in-Canada-report-May-2021.pdf. Accessed March 2022. 3 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/ Accessed March 2022. 4 Canadian Association of Optometrists. Glaucoma fact sheet. Retrieved from https://opto.ca/health-library/about-glaucoma. Accessed March 2022. 5 Canadian Association of Optometrists. Glaucoma fact sheet. Retrieved from https://opto.ca/health-library/about-glaucoma. Accessed March 2022. 6 Leger Research. Glaucoma Survey commissioned by Allergan, an AbbVie Company. Online survey of 150 Canadians who have been diagnosed with glaucoma, between February 24-26, 2022, using Leger’s online panel

SOURCE Allergan, an AbbVie Company

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2022/09/c3454.html

AbbVie Announces Provincial Reimbursement for VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) in Alberta, Saskatchewan, British Columbia, and Manitoba

MONTREAL, Feb. 24, 2022 /CNW/ – AbbVie (NYSE: ABBV) announced today that Alberta, Saskatchewan, British Columbia, and Manitoba now reimburse 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.¹ For full funding criteria, consult the list of medications in effect in each province.^2,3,4,5 The combination treatment is also listed on the Drug Benefit List in the Non-Insured Health Benefits (NIHB) Program⁶ and has been on Québec’s Listes des médicaments – Établissements since last November.⁷

“As a clinician, it’s always best to have several treatment options available for my patients to treat their CLL. It is great news that venetoclax plus obinutuzumab is now reimbursed for Western Canadians,” says Dr. Carolyn Owen, MD, MDres(UK), FRCPC, Associate Professor, Division of Hematology and Hematological Malignancies, Foothills Medical Centre. “Venetoclax is an innovative molecule that selectively inhibits the BCL-2 protein, which is responsible for helping cancer cells survive in the blood. We have been awaiting this time-limited targeted therapy option for CLL patients.”

VENCLEXTA plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated CLL.

“Lymphoma Canada is pleased that this combination therapy is now available in British Columbia, Alberta, Saskatchewan and Manitoba 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 additional treatment options in the frontline setting,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

VENCLEXTA in combination with obinutuzumab, is the third indication for VENCLEXTA for the treatment of CLL. VENCLEXTA is 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 patients with CLL with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options.¹

“We are very proud of this tremendous milestone. VENCLEXTA plus obinutuzumab is now reimbursed in Alberta, Saskatchewan, British Columbia, and Manitoba for people living with CLL. This combination is a much-needed treatment option and reinforces our commitment in Oncology. At AbbVie, we stand by our mission to transform the standard of care for people living with cancer,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

CLL, which is typically a slow-progressing cancer of the bone marrow and blood, 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.⁸

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 AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.

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.ca. Follow AbbVie Canada on Twitter, on Instagram or find us on LinkedIn.

________________________________

1 AbbVie Corporation Venclexta(R) (venetoclax) Product Monograph. Date of Preparation: September 27, 2016. Date of Revision: January 21, 2021.https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf Accessed February 23, 2022.

2 BC Cancer. http://www.bccancer.bc.ca/systemic-therapy-site/Documents/2022%20ST%20Updates/ST%20Update_Feb%202022.pdf. Accessed February 23, 2022.

3 Saskatchewan Cancer Agency. http://www.saskcancer.ca/images/pdfs/health_professionals/drug_formulary/drug_formulary/SCA_Drug_Formulary_-_2022-02-01.pdf. February 23, 2022.

4 Cancer Care Alberta. https://www.albertahealthservices.ca/assets/programs/ps-1025651-drug-benefit-list.pdf. Accessed February 23, 2022.

5 Manitoba Health. Manitoba Drug Benefits and Manitoba Drug Interchangeability Formulary Amendments. https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin116.pdf. Accessed February 23, 2022.

6 Non-Insured Health Benefits (NIHB) Drug Benefit List. https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407. Accessed February 23, 2022.

7 Régie de l’assurance maladie du Québec’s Listes des médicaments – Établissements. https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments-fournis-etablissement. Accessed February 23, 2022.

8 Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics.www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed February 23, 2022.

SOURCE AbbVie Canada

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/February2022/24/c1878.html

#WorldSightDay – All Eyes Encouraged to Focus on Glaucoma

New national survey reveals 45% of Canadians 50+ are not aware that glaucoma is one of the leading causes of blindness in Canada

Montreal, QC, October 14, 2021 – Today is World Sight Day, a timely opportunity to define the importance of proactive vision care and increase understanding of glaucoma. Glaucoma is an eye disease where increased eye pressure (intraocular pressure) can damage the optic nerve and lead to
permanent vision loss.1

In a new national survey conducted by Leger Research, 45 per cent of Canadians 50+ are not aware that glaucoma is one of the leading causes of blindness in Canada.2

The survey also revealed that 42 per cent of Canadians 50+ have not seen an optometrist within the last 18 months. Furthermore, 24 per cent of Canadians 50+ have experienced vision strain from increased screen time within the last 18 months. Lastly according to the survey, Albertans, Ontarians, Quebecers,
and Atlantic Canadians are significantly more likely to say they suffered vision strain from extra time on computer monitors, smart phones, e-readers and watching television compared to Canadians over 50 in the Prairies.

Glaucoma – Stop the Thief of Sight

It’s estimated 400,000 Canadians are impacted by glaucoma.3
A ‘thief of sight,’ glaucoma develops slowly over time, making it difficult to notice any symptoms. Canadians living with glaucoma may experience a gradual narrowing of their peripheral vision. There is no cure for glaucoma and if not proactively managed it will cause optic nerve damage leading to irreversible loss of sight.3

However, optometrist and ophthalmologists can detect and manage glaucoma. Canadians are encouraged to learn about the effects of glaucoma, and access resources for additional support such as the glaucoma section of the Fighting Blindness Canada website (FightingBlindness.ca).

Glaucoma in Perspective (GiP)

In partnership with Fighting Blindness Canada, Allergan has developed the Glaucoma in Perspective (GiP) app designed to help patients understand the impact of their glaucoma and disease progression.

Created by Professor David Crabb, the GiP app was developed with research and insights into patients’ perception of sight loss with glaucoma. GiP has been used across the United Kingdom with great success and is being adapted for Canada. The Glaucoma in Perspective (GiP) app is coming soon to the Apple Store and Google Play for free download.

#WorldSightDay

To recognize #WorldSightDay, the International Agency for the Prevention of Blindness (IAPB.org) has gathered a group of leading global vision organizations and launched the #LoveYourEyes campaign, encouraging one million people around the world to get their eyes checked by Oct. 14th.

Statements:

• “World Sight Day is an important event that is coming at an especially timely moment as the pandemic has now been amongst us for over 20 months. Every week, I see several patients that have been lost to follow-up for over a year due to COVID fears of seeing their eye care team and they have now suffered cataclysmic and irreversible loss of vision in one or both eyes. Most
  common diseases like cataract or macular degeneration have early and noticeable symptoms for patients. Glaucoma usually damages the peripheral vision first, so it can go unnoticed by patients as the disease worsens, and thus is known as the “silent thief of sight”. The pandemic has been a tragic eye opener to the consequences of delayed health care in so many areas of
  medicine, and we must do everything possible to address its glaucoma impact right now.” – Dr. David B. Yan, Ophthalmologist-in-Chief, Mount Sinai Hospital, University of Toronto – Glaucoma Service Director, Kensington Eye Institute.
• “There is no cure for glaucoma. It’s why research is critical. However, early detection and treatment can help prevent damage to the optic nerve and save vision. Anyone can develop glaucoma but there are several different factors that can increase your risk of developing the disease. Know your risks. See your eye care professional annually to establish your eye health baseline. You are not alone. FightingBlindness.ca has tremendous resources to help and there is support and resources like the Glaucoma in Perspective (GiP) app will help manage the effects of glaucoma.” – Doug Earle, President & CEO, Fighting Blindness Canada.
• “Patients with glaucoma don’t normally exhibit symptoms of vision loss until they receive a proper eye exam. The purpose of the GiP app is to simplify glaucoma to ensure that doctors are able to explain the disease and show an accurate visual representation of glaucoma to newly diagnosed patients. This is an app that makes it simple for patients to adhere to treatment and share information about their disease to their loved ones.”- Dr. Professor David Crabb, GiP app developer and Professor of Statistics and Vision Research, City University London.
• “Our purpose in Glaucoma is to create a future where people’s vision lasts a lifetime. We understand the importance of eye care, and that’s why we continue to search for new treatments to help preserve and protect our patients’ vision. We’ve been creating innovative products and services for healthcare providers and patients for over 70 years, and we challenge
  what’s possible each and every day. We’re proud to launch the new Glaucoma in Perspective (GiP) app in partnership with Fighting Blindness Canada and remain committed to supporting Canadians living with and managing eye diseases.” – Tracey Ramsay, Vice President and General Manager, AbbVie Canada.

About the Survey

Commissioned by Allergan, an AbbVie Company, the survey was conducted using Leger’s online panel between September 10 to 12, 2021 with 684 Canadians aged 50 and over. The estimated margin of error is ±3.75%, 19 times out of 20.

About Fighting Blindness Canada

Fighting Blindness Canada (FBC) is Canada’s leading private funder of vision research. FBC offers hope to Canadians by identifying the best, most promising research that is driving treatments and cures for blinding eye diseases, and by raising and stewarding funds to support this essential, sight-saving research. Over our 45-year history, FBC has invested over $40 million to support vision research and education across Canada: that’s over 200 research grants that have led to over 600 new discoveries in areas such as stem cell research, neuroprotective therapies, technological developments,
pharmaceuticals, and gene therapies. FBC is also committed to developing vision research funding partnerships in Canada and internationally. Through these partnerships, FBC has helped to unlock more than $10 million to drive research forward. All of the research and educational initiatives funded support the goals of understanding why vision loss occurs, how it can be slowed or stopped, and how sight can be restored.

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.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.

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Media:
Muriel Haraoui
AbbVie Canada
514-717-3764
muriel.haraoui@abbvie.com

1 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/wpcontent/uploads/2021/03/FBC_OnePager_Glaucoma.pdf . Accessed October 13, 2021
2 Canadian Association of Optometrists. About Glaucoma. Retrieved from https://opto.ca/health-library/about-glaucoma. Accessed
October 13, 2021.
3 Fighting Blindness Canada. About Glaucoma. Retrieved from https://www.fightingblindness.ca/eyehealth/eye-diseases/glaucoma/
Accessed October 13, 2021.