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Cision Canada
4 days ago
- Business
- Cision Canada
VABYSMO® (faricimab injection) Now Publicly Funded For Macular Edema Secondary to Retinal Vein Occlusion (RVO) and Pre-Filled Syringe (PFS) in Quebec Français
Vabysmo now covered across all three approved indications in the province, providing patients with a comprehensively funded option for their needs MISSISSAUGA, ON, Aug. 15, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce today that VABYSMO ® (faricimab injection) is now publicly funded for macular edema secondary to retinal vein occlusion (RVO) on the Régie de l'assurance maladie du Québec (RAMQ) list of medications. 1 This latest update also includes funding for Vabysmo in a 6.0 mg single-use pre-filled syringe (PFS), providing an additional option and expanded access for patients in Quebec. Vabysmo received Health Canada authorization for treatment of macular edema secondary to retinal vein occlusion (RVO) in July 2024, and the approval of the PFS format in December 2024. 2 "This expansion in coverage for people with RVO in Quebec is welcome news in our mission to advance eye care and provide innovative solutions for people living with serious retinal conditions," said Carlene Todd, Vice President, Access at Roche Pharmaceuticals Canada. "We are deeply committed to ensuring equitable and timely access to our treatments, ensuring that provinces across the country prioritize access to innovative medicines that will ultimately improve the lives of people impacted by vision loss." With this latest listing, Vabysmo is now covered in Quebec for all three of its indications and in both formats, including neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and the latest, macular edema secondary to retinal vein occlusion (RVO). These leading causes of vision loss affect around 70 million people worldwide and can have a serious impact on patients, their families, and caregivers. 3,4,5,6 "The recent reimbursement for RVO in Quebec is a significant step forward for people living with the condition," said Dr. Ananda (Andy) Kalevar, Associate Professor, Department of Ophthalmology at Sherbrooke University, Quebec. "It gives ophthalmologists a valuable treatment option and provides patients with access to a medication that may ultimately offer the best outcomes for their vision." Roche Canada is committed to continuing to work with remaining provincial jurisdictions to make Vabysmo available through public and private drug plans for those living with RVO. About retinal vein occlusion (RVO) RVO is the second most common cause of vision loss due to retinal vascular conditions. It affects an estimated 28 million adults globally, mainly those aged 60 or older, and can lead to severe and sudden vision loss. 3,7 There are two main types of RVO: branch RVO (BRVO), which affects more than 23 million people globally and occurs when one of the four smaller 'branches' of the main central retinal vein becomes blocked; and central RVO (CRVO), which is less common, affecting more than four million people worldwide, and occurs when the eye's central retinal vein becomes blocked. 3,8 The levels of Vascular Endothelial Growth Factor A (VEGF-A) and angiopoietin-2 (Ang-2) are elevated in RVO and it is thought that their increased expression drives disease progression. 9,10 RVO typically results in sudden, painless vision loss in the affected eye because the vein blockage restricts normal blood flow in the affected retina, resulting in ischemia, bleeding, fluid leakage and retinal swelling called macular edema. 7,11,8 The safety and efficacy of Vabysmo for the treatment of macular edema secondary to retinal vein occlusion (RVO) were assessed in two randomised, multi-centre, double-masked, studies in patients with macular edema secondary to BRVO (BALATON) or CRVO/hemiretinal vein occlusion (HRVO) (COMINO). Between Week 24 and Week 72, for patients who received faricimab Q4W/faricimab PTI, 49% of patients in BALATON and 34% of patients in COMINO completed at least one cycle of every 12 weeks (Q12W) and maintained ≥ Q12W dosing without an interval reduction below Q12W through Week 68; 32% of patients in BALATON and 24% of patients in COMINO completed 2 cycles of Q16W through Week 72. 2 About Vabysmo ® (faricimab injection) Vabysmo is a humanized bispecific immunoglobulin G1 (IgG1) antibody that acts through inhibition of both Ang-2 and vascular endothelial growth factor A (VEGF-A). By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability. By inhibiting Ang-2, faricimab is thought to increase vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with wet AMD, DME, and RVO. 2 In Canada, Vabysmo is authorized for the treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema secondary to retinal vein occlusion (RVO). 2 To date, Vabysmo is approved in more than 100 countries for DME and nAMD, and in over 30 countries for macular edema following retinal vein occlusion (RVO). 12,13,14,15,16,17 About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and sustainable healthcare systems. We are committed to creating a world where we all have more time with the people we love. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and healthcare systems expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs nearly 2,000 people at its offices in Mississauga, Ontario, in Laval, Quebec, and across the country from coast to coast to coast. For more information, please visit or follow Roche Canada on LinkedIn. References [1] RAMQ List of medications. Available at: Accessed on August 14, 2025. [2] Vabysmo Product Monograph, July 25, 2025 [3] Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. Song P, et al. Global epidemiology of retinal vein occlusion: a systematic review and meta-analysis of prevalence, incidence, and risk factors. J Glob Health. 2019; 9:010427. [4] Yau JWY, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012; 35:556–64. [5] Connolly E, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102:1691–95. [6] Bright Focus Foundation. Age-Related Macular Degeneration: Facts & Figures [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [7] Moorfields Eye Hospital, United Kingdom National Health Service Foundation Trust. RVO [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [8] Campochiaro P. Molecular pathogenesis of retinal and choroidal vascular diseases. Prog Retin Eye Res. 2015; 49:67-81. [9] Joussen et al. Angiopoietin/Tie2 signalling and its role in retinal and choroidal vascular diseases: a review of preclinical data. Eye. 2021; 35:1305-1316. [10] Regula JT, et al. Targeting key angiogenic pathways with a bispecific CrossMab optimised for neovascular eye diseases. EMBO Molecular Medicine. 2016; 8:1265–88. [11] Schmidt-Erfurth U, et al. Guidelines for the management of retinal vein occlusion by the European society of retina specialists (EURETINA). Ophthalmologica. 2019; 242:123-162. [12] U.S. Food and Drug Administration (FDA). Highlights of prescribing information, aflibercept 2 mg. 2022. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [13] FDA. Highlights of prescribing information, Vabysmo. 2022. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [14] FDA approves Genentech's Vabysmo for the treatment of RVO [Internet; cited August 2025]. Available from: Accessed on August 6, 2025 [15] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [16] European Medicines Agency. Summary of product characteristics, Vabysmo, 2022 [Internet; cited August 2025]. Available from: Accessed on August 6, 2025. [17] Roche Data on File SOURCE Hoffmann-La Roche Limited (Roche Canada)
Cision Canada
11-06-2025
- Health
- Cision Canada
Health Canada Authorizes PiaSky® (crovalimab for injection) As the First Monthly (Every Four Weeks) Subcutaneous Treatment for People With Paroxysmal Nocturnal Hemoglobinuria (PNH) Français
PiaSky® is the first monthly (every four weeks) subcutaneous treatment for PNH in Canada with the option to self-administer following adequate training (1) PiaSky® (crovalimab for injection) has the potential to help reduce treatment burden for people with PNH in Canada and their caregivers (2, 3) MISSISSAUGA, ON, June 11, 2025 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has authorized PiaSky® (crovalimab for injection) as the first monthly (every four weeks) subcutaneous therapy indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults and adolescents 13 years of age and older with a body weight of at least 40 kg. (1) "We are pleased to offer PiaSky as a new option to the treatment landscape for Canadians living with PNH," said Brigitte Nolet, President and CEO, Roche Pharma Canada. "With a self-administration option available for appropriate patients, as determined by their doctor, individuals can choose to treat their disease at home without requiring IV access, and feel empowered to take an active role in their own care. This flexibility of administration may help reduce treatment burden for patients, their caregivers, and healthcare systems, and is part of Roche's ongoing commitment to bringing Canadians new therapies that have a broader value to society." PNH is a rare, genetically acquired, and life-threatening disease of the bone marrow where red blood cells deficient in certain protective markers are destroyed by the complement system, which helps defend against infection. (4) The destruction of these abnormal blood cells lead to symptoms such as anemia, fatigue, hemoglobinuria (blood in the urine), and blood clots. (5, 6) Globally, the estimated prevalence of PNH is estimated at 15.9 cases per million, affecting fewer than 1,000 individuals in Canada. (7) Complement component 5 (C5) inhibitors – treatments that block part of the complement system cascade – have been shown to be effective in treating PNH. (4, 5, 6, 8) "The approval of crovalimab, a novel C5 inhibitor, provides further freedom of choice for patients with PNH receiving terminal complement blockade," said Dr. Christopher Patriquin, Chair of the Canadian PNH Network and Assistant Professor of Medicine and Clinician Investigator at the University of Toronto. "Blocking C5 directly was the first approved strategy for treating such patients, and this new drug will allow them another option. They can now choose to get the disease-controlling treatment in small-volume, subcutaneous doses every 4 weeks, and even, in appropriate cases, self-administer them, instead of the other available C5 inhibitors which are given intravenously." "Monthly (every four weeks) self-injection of crovalimab has the potential to improve the quality of life for people living with PNH," said Barry Katsoff, President, Canadian Association of PNH Patients. "The potential for a more manageable, home-administered solution is especially meaningful for PNH patients whose daily lives are often disrupted by the demands of ongoing therapy. Canadian patients welcome the introduction of crovalimab to our basket of options." Health Canada's authorization of PiaSky is based on the pivotal COMMODORE 2 Phase III study in people with PNH who have not previously been treated with C5 inhibitors. (1, 9, 10) The study demonstrated that PiaSky, administered as subcutaneous (SC) injections every four weeks, achieved disease control (as measured by hemolysis control and transfusion avoidance) and was well-tolerated. (1) Roche Canada is committed to working with the provincial and territorial jurisdictions to make PiaSky available as soon as possible through public and private drug plans for the patients who need it. About paroxysmal nocturnal hemoglobinuria (PNH) PNH is a rare hematological disease that may develop on its own or in the context of other bone marrow disorders such as aplastic anemia. Somatic mutations to the PIGA gene lead to clonal expansion of hematopoietic stem cells in the bone marrow which lack certain protein cell surface markers. The absence of these markers renders blood cells susceptible to lysis by the complement system, part of our innate immune defense against common pathogens. These processes cause anemia, thrombosis (blood clots), fatigue, and other debilitating symptoms that significantly impact quality of life and mental health. Individuals can be diagnosed at any stage of life, but are most commonly diagnosed in their 30's or 40's. (5, 6, 11, 12) About PiaSky ® [crovalimab for injection] PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5 and is designed to block the complement system. (1, 10) It is recycled within the bloodstream, allowing the medicine to bind and inhibit the C5 protein multiple times and to act longer in the body with a small volume of medicine. (1, 13) Individuals will have the option to self-administer PiaSky following an initial intravenous (IV) infusion and weekly subcutaneous (SC) loading doses in the first month of treatment, in appropriate cases following adequate training. (1) PiaSky's flexibility of administration may help to reduce treatment burden and disruption to the lives of people with PNH and their caregivers. (2, 3) About the COMMODORE 2 study The COMMODORE 2 study is a Phase III, randomised, open-label study evaluating the efficacy and safety of PiaSky® (crovalimab for injection) versus eculizumab in people with paroxysmal nocturnal hemoglobinuria who have not been treated previously with C5 inhibitors. The study's co-primary efficacy endpoints measure transfusion avoidance and control of hemolysis (the ongoing destruction of red blood cells measured by lactate dehydrogenase levels). The adults enrolled in the study were randomised in a 2:1 ratio to be treated with either subcutaneous (SC) PiaSky every four weeks or intravenous eculizumab every two weeks. The participants who were less than 18 years old were included in a non-randomised treatment arm and were treated with SC PiaSky every four weeks. (9, 10) About Roche Canada At Roche Canada, patients and science are at the heart of everything we do. Our passion for science and our commitment to relentlessly pursuing the impossible for patients have made us one of the world's leading pharmaceutical, in-vitro diagnostics, and diabetes care management companies. With our combined strength in diagnostics and pharmaceuticals, we're driving healthcare forward, while ensuring we deliver meaningful benefits for patients and a sustainable healthcare system. Because we're committed to making quality healthcare accessible to everyone. And we're adding our expertise in new areas, such as artificial intelligence, real world data collection and analysis and collaborating with many different sectors and industries. Having the courage to reinvent ourselves and question the status quo is what patients and the healthcare system expect from Roche - and our commitment is as strong today as it was on the first day of our Canadian journey in 1931. Today, Roche Canada employs more than 1,800 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics and Diabetes Care divisions in Laval, Quebec. PiaSky Product Monograph, June 4, 2025 Roth A, Nishimura JI, Nagy Z, Gaal-Weisinger J, Panse J, Yoon SS, et al. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020;135(12):912–20. Sampei Z, Haraya K, Gan SW, Muraoka M, Hayasaka A, Fukuzawa T, et al. Beyond Recycling Antibodies: Crovalimab's Molecular Design Enables Four-Weekly Subcutaneous Injections for PNH Treatment. Int J Mol Sci. 2024;25(21). Shah N, Bhatt H. Paroxysmal nocturnal hemoglobinuria. StatPearls. Treasure Island (FL) 2022. Schrezenmeier H, Roth A, Araten DJ, Kanakura Y, Larratt L, Shammo JM, et al. Baseline clinical characteristics and disease burden in patients with paroxysmal nocturnal hemoglobinuria (PNH): updated analysis from the International PNH Registry. Ann Hematol. 2020;99(7):1505–14. Patriquin CJ, Kiss T, Caplan S, Chin-Yee I, Grewal K, Grossman J, et al. How we treat paroxysmal nocturnal hemoglobinuria: a consensus statement of the Canadian PNH Network and review of the national registry. Eur J Haematol. 2019;102(1):36–52. Hill A, Platts PJ, Smith A, Richards SJ, Cullen MJ, Hill QA, et al. The incidence and prevalence of paroxysmal nocturnal hemoglobinuria (PNH) and survival of patients in Yorkshire. Blood. 2006;108:985. Hillmen P, Young NS, Schubert J, Brodsky RA, Socie G, Muus P, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2006;355(12):1233–43. COMMODORE 2 (NCT04434092). [Internet; cited June 2025] Available at: Roth A, He G, Tong H, Lin Z, Wang X, Chai-Adisaksopha C, et al. Phase 3 randomized COMMODORE 2 trial: Crovalimab versus eculizumab in patients with paroxysmal nocturnal hemoglobinuria naive to complement inhibition. Am J Hematol. 2024;99(9):1768-77. Oliver MP, C. Paroxysmal Nocturnal Hemoglobinuria: Current Management, Unmet Needs, and Recommendations. J Blood Med. 2023:613-28. Parker C, Omine M, Richards S, Nishimura J, Bessler M, Ware R, et al. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. Blood. 2005;106(12):3699–709. Fukuzawa T, et al. Long lasting neutralisation of C5 by SKY59, a novel recycling antibody, is a potential therapy for complement-mediated diseases. Sci Rep. 2017;7(1):1080. SOURCE Hoffmann-La Roche Limited (Roche Canada)
