Roche announces U.S. FDA accepted sBLA for Gazyva/Gazyvaro

Roche (RHHBY) announced that the US Food and Drug Administration has accepted the company’s supplemental Biologics License Application, sBLA, for Gazyva/Gazyvaro for the treatment of systemic lupus erythematosus, SLE. 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/Gazyvaro is already approved for adults with lupus nephritis in the US and EU.