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 at least a four-point improvement in the SLE Responder Index (SRI-4) — a measurement tool that evaluates disease severity and symptoms — compared with 53.5% with placebo plus standard therapy.
A decision on approval is expected by December 2026. Currently, Gazyva is approved in the U.S. and European Union for the treatment of adults with active lupus nephritis.
Tags: SLE, systemic lupus erythematosus, approval, treatment, Genentech, Gazyva, obinutuzumab, FDA