Hoffmann-La Roche Limited (Roche Canada) said Canada’s Drug Agency (CDA-AMC) has recommended Gazyva (obinutuzumab) for public reimbursement for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. The recommendation, issued on May 6, 2026, follows Health Canada’s authorization of Gazyva for this indication in January 2026 and is expected to broaden patient access through public drug plans.
Lupus affects about 1 in 1,000 people in Canada, and nearly 40% of those individuals develop lupus nephritis, a kidney-specific manifestation of systemic lupus erythematosus (SLE). SLE is a systemic autoimmune disease that can involve the skin, joints and blood system, while lupus nephritis occurs when the immune system attacks the kidneys, which can impair kidney function and, in some cases, lead to kidney failure.
“This positive recommendation brings us one step closer to providing a much-needed treatment option for those living with active lupus nephritis,” said Dr. Daniel Edgcumbe, vice-president, Medical and Regulatory Affairs, Roche Canada. He noted that the significant unmet need highlighted during Lupus Awareness Month is a key motivation for Roche’s continued work in this complex disease area.
The CDA-AMC decision is supported by results from the Phase 3 REGENCY study, which evaluated Gazyva plus standard therapy versus standard therapy alone in adults with active lupus nephritis. Nearly half of participants (46.4%) receiving Gazyva in combination with standard therapy achieved a complete renal response, compared with 33.1% of those on standard therapy alone. The trial also showed a statistically significant reduction in corticosteroid use and an improvement in proteinuric response among patients treated with Gazyva.
Roche Canada said it welcomes CDA-AMC’s recognition of the clinical evidence and patient benefit associated with Gazyva in lupus nephritis and remains committed to working with provincial and territorial authorities to secure reimbursement. The company’s stated goal is to make Gazyva available as soon as possible through both public and private drug plans for eligible patients.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!