SLE

FDA Accepts Application for Gazyva® (obinutuzumab) to Treat SLE

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The U.S. Food and Drug Administration has accepted the supplemental Biologics License Application from Genentech for Gazyva® (obinutuzumab) to treat systemic lupus erythematosus (SLE), the most common form of lupus. The acceptance is based on Phase 3 data showing that Gazyva significantly reduced disease activity and less reliance on steroids in people with SLE.   According to results published in the New England Journal of Medicine and presented at SLEuro 2026, more than 75% of people treated with Gazyva plus standard therapy achieved … FDA Accepts Application for Gazyva® (obinutuzumab) to Treat SLE

Lupus Research Alliance Applauds U.S. FDA Fast Track Designation for Nipocalimab for Systemic Lupus Erythematosus 

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Decision Could Help Potential SLE Treatment Reach People Living With Lupus Sooner The Lupus Research Alliance applauds the decision by the U.S. Food and Drug Administration (FDA) to grant Fast Track designation for nipocalimab in development by Johnson & Johnson for the treatment of adults with systemic lupus erythematosus (SLE) – a chronic autoimmune disease for which there are few treatment options. The FDA grants this designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need” – with the goal of … Lupus Research Alliance Applauds U.S. FDA Fast Track Designation for Nipocalimab for Systemic Lupus Erythematosus