FDA Accepts Roche’s sBLA for Gazyva in Lupus Nephritis Treatment

Roche has announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for treating lupus nephritis, with a final decision expected by October 2025. The submission is backed by the Phase III REGENCY study, which demonstrated that Gazyva, when combined with standard therapy, significantly improved complete renal response (CRR) compared to standard treatment alone. The findings, recently presented at the World Congress of Nephrology and published in the New England Journal of Medicine, offer hope for better kidney preservation and reduced progression to end-stage renal disease in affected patients.

This advancement is crucial for lupus nephritis patients, who face a high burden of disease, often leading to kidney failure and requiring dialysis or transplantation. “A new treatment option like Gazyva has the potential to reduce these risks and improve quality of life,” said Louise Vetter, CEO of the Lupus Foundation of America. If approved, Gazyva will be the first anti-CD20 monoclonal antibody in a Phase III trial to show a CRR benefit in lupus nephritis, marking a significant step forward in addressing an urgent medical need.