Gazyva® (obinutuzumab) receives positive reimbursement recommendation from the Institut national d'excellence en santé et en services sociaux (INESSS) for persons with active lupus nephritis

• The INESSS recommendation is the latest step towards public access to Gazyva (obinutuzumab) for persons with active lupus nephritis who are receiving standard therapy ¹
• Provincial jurisdictions will make the final decision on public reimbursement

MISSISSAUGA, ON, June 25, 2026 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) is pleased to share that on June 3, 2026, the Institut national d'excellence en santé et en services sociaux (INESSS) recommended Gazyva (obinutuzumab) for public reimbursement in Quebec. This recommendation is for the treatment of persons with active lupus nephritis who are receiving standard therapy.¹ This positive recommendation expands the pathway to patient access, following Canada's Drug Agency's positive recommendation on May 6, 2026 and Health Canada's authorization in January 2026.^2,3

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.

"This positive recommendation from INESSS is an important milestone towards equitable access for patients with active lupus nephritis in Quebec," said Simon Yunger, Vice-President, Value, Pricing and Reimbursement at Roche Canada. "This decision underscores the clear therapeutic value Gazyva delivers. Roche Canada remains fully committed to working with Quebec and all provincial and territorial jurisdictions to ensure Gazyva is made available swiftly through public drug plans."

The INESSS decision was supported by evidence from the phase III REGENCY study that showed 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.⁶ Data showed a statistically significant reduction of corticosteroid use and an improvement in proteinuric response.^6,7

Roche Canada is delighted INESSS has recognized the clinical evidence and benefit shown by Gazyva for people in Quebec living with lupus nephritis. As the file proceeds to the pan-Canadian Pharmaceutical Alliance (pCPA) for pricing negotiations, we remain focused on securing broad public and private drug plan coverage across all provinces and territories.

About Lupus Nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.⁸ 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.⁹

Lupus nephritis affects more than 1.7 million people worldwide – predominantly women, mostly of colour and usually of childbearing age^.10 Currently, there is no cure.⁸

About Gazyva
Gazyva (obinutuzumab) is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells.¹¹ In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys and reduces their ability to function properly.¹² 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.⁷

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. L'Institut national d'excellence en santé et en services sociaux: https://www.inesss.qc.ca/thematiques/medicaments/medicaments-evaluation-aux-fins-dinscription/extrait-davis-au-ministre/gazyva-nephrite-lupique-active-7725.html
2. Canada's Drug Agency - L'Agence des medicaments du Canada: https://www.cda-amc.ca/obinutuzumab
3. Roche Canada, Health Canada authorizes Gazyva® (obinutuzumab) for adults with active lupus nephritis, January 2026. Available from: https://www.rochecanada.com/media/health-canada-authorizes-gazyva-obinutuzumab-for-adults-with-active-lupus-nephritis
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. Gazyva Product Monograph, January 22, 2026
7. Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.
8. 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.
9. Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-38.
10. Anders HJ et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.
11. 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.
12. 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)

Media Contact: Jolinne Kearns, Communications Manager, Roche Canada, 416-726-7699, [email protected]