Roche’s Genentech reports FDA approval of sBLA for Gazyva

Genentech, a member of the Roche (RHHBY) Group, announced today that the U.S. FDA has accepted the company’s supplemental Biologics License Application for Gazyva for the treatment of systemic lupus erythematosus. The filing acceptance is based on positive results from the Phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 at 52 weeks – a measure that assesses changes in disease severity, symptoms and physical condition. The FDA is expected to make a decision on an approval by December 2026. Gazyva is already approved for adults with lupus nephritis in the US and EU.