Company Announcements

The approval introduces the first and only anti-CD20 monoclonal antibody shown to improve complete renal response in lupus nephritis, offering a new treatment option for patients and potentially delaying or preventing end-stage kidney disease. ^1,2,3

MISSISSAUGA, ON , Jan. 26, 2026 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that on January 22, 2026, Health Canada has approved Gazyva® (obinutuzumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. Following four initial doses in the first year, Gazyva can be administered twice yearly, offering an effective and potentially more convenient treatment option than traditional targeted therapies.³

"Roche Canada is committed to bringing the best innovation in healthcare to Canadians when they need it most. This milestone for Gazyva is a testament to that vision," said Dr. Daniel Edgcumbe, Vice-President, Medical and Regulatory Affairs, Roche Canada. "For Canadians facing lupus nephritis, a disease with no current cure, this represents our ongoing commitment to providing new therapeutic options for lupus nephritis patients." 

In Canada, lupus affects approximately 1 in 1,000 people.⁴ Among those with lupus, nearly 40% develop lupus nephritis, a kidney-specific form of systemic lupus erythematosus (SLE)⁵. SLE is a broader autoimmune disease that can affect various organs, such as the skin, joints, and blood system. Lupus nephritis occurs when the immune system mistakenly attacks the kidneys, potentially leading to impaired kidney function or even kidney failure.

"Lupus nephritis is one of the most frequent, severe, and debilitating complications of systemic lupus erythematosus, and treatment options are unfortunately limited," said Dr. Ann Clarke, Professor in the Division of Rheumatology, Department of Medicine, Cumming School of Medicine, University of Calgary. "Health Canada's approval of Gazyva represents a significant advancement in lupus treatment, offering renewed hope to those living with lupus nephritis by improving kidney outcomes and long-term overall health."

Health Canada's authorization of Gazyva is based on results from the Phase II NOBILITY and phase III REGENCY studies. In REGENCY, data showed that nearly half of the participants (46.4%) on Gazyva in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone. That means that adding Gazyva to the current standard of care treatment was more effective than the standard of care treatment alone. Data showed a statistically significant and clinically meaningful increase in the proportion of patients who achieved complete renal response with reduced corticosteroid use and an improvement in proteinuric response, all signalling improved disease control.² The safety profile of Gazyva was consistent with the well-characterised profile observed in its haematology-oncology indications.³

"Lupus nephritis is a complex and unpredictable disease that places a significant burden on patients and families," said Leanne Mielczarek, CEO, Lupus Canada. "Ongoing symptoms and disease flares affect not only physical health but also mental well-being, work, and daily life. Gazyva represents an important new treatment option for Canadians living with lupus nephritis, and Health Canada's approval expands access to much-needed evidence-based therapies for patients and the clinicians who care for them."

Roche Canada is committed to working with the provincial and territorial jurisdictions to make Gazyva available as soon as possible through public and private drug plans for the patients who need it.

About Lupus Nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.⁶ Lupus nephritis is characterised by an irreversible loss of nephrons, the filtering structures of the kidneys. Periods of intense disease activity, known as flares, can speed up the loss of nephrons and, if left unchecked, may lead to a progressive loss of kidney function. Even with the latest treatments, up to a third of people will progress to end-stage kidney disease, where dialysis or transplant are the only options and life expectancy and quality of life are substantially reduced.⁷

Lupus nephritis affects more than 1.7 million people worldwide – predominantly women, mostly of colour and usually of childbearing age.⁸ Currently, there is no cure.⁶

About Gazyva
Gazyva (obinutuzumab) is a Type II engineered humanised monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.⁹ In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.¹⁰ Data suggests that Gazyva depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.²

Gazyva is approved for adults with lupus nephritis in Canada, the United States and European Union and in over 100 countries for various types of haematological cancers.

About the REGENCY Study
REGENCY [NCT04221477] is a phase III, randomised, double-blind, placebo-controlled, multicentre study investigating the efficacy and safety of Gazyva (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomised 1:1 to receive either Gazyva plus standard therapy or placebo plus standard therapy. The study population was representative of the real-world population of people with lupus nephritis.

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 almost 2,000 people across the country through its Pharmaceuticals division in Mississauga, Ontario as well as its Diagnostics division in Laval, Québec.

For more information, please visit www.RocheCanada.com or follow Roche Canada on LinkedIn.

All trademarks used or mentioned are the property of its respective owners.

References
1. Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.
2. Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.
3. Gazyva Product Monograph, January 22, 2026
4. Lupus Canada; [cited 2026 January 7]. Available from: https://www.lupuscanada.org/what-is-lupus/
5. Hanly JG,et al. The frequency and outcome of lupus nephritis: results from an international inception cohort study. Rheumatology (Oxford). 2016 Feb;55(2):252-62.
6. Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 Apr;75(4):567-573.
7. Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-38.
8. Anders HJ et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.
9. Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
10. Atisha-Fregoso Y, et al. Meant to B: B cells as a therapeutic target in systemic lupus erythematosus. J Clin Investig. 2021 Jun 15;131(12):e149095.

SOURCE Hoffmann-La Roche Limited (Roche Canada)