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Positive Phase III Data for Genentech's Gazyva Show Significant Reduction in Disease Activity for Systemic Lupus Erythematosus
Businesswire· 2025-11-03 06:00
Core Insights - Genentech, a member of the Roche Group, announced significant results from the Phase III ALLEGORY study of Gazyva (obinutuzumab) for adults with systemic lupus erythematosus (SLE) [1] Study Results - The study met its primary endpoint, demonstrating a higher percentage of patients achieving a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva [1]
Positive Phase III Results for Genentech's Gazyva in Children and Young Adults With Idiopathic Nephrotic Syndrome
Businesswire· 2025-10-28 06:00
Core Insights - Genentech, a member of the Roche Group, announced significant results from the Phase III INShore study of Gazyva (obinutuzumab) for treating idiopathic nephrotic syndrome in children and young adults aged 2-25 years [1] Group 1 - The Phase III INShore study met its primary endpoint, demonstrating that more patients achieved sustained complete remission at one year (week 52) with Gazyva compared to mycophenolate mofet [1]
FDA Approves Genentech's Gazyva for the Treatment of Lupus Nephritis
Businesswire· 2025-10-20 05:00
Core Insights - The FDA has approved Gazyva® (obinutuzumab) for treating adult patients with active lupus nephritis (LN) who are on standard therapy [1] - The approval includes a new shorter infusion time of 90 minutes after the first infusion for eligible patients [1] - Gazyva can be administered twice a year following four initial doses in the first year [1]