FDA accepts Roche’s Gazyva/Gazyvaro sBLA for lupus nephritis

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis submitted by Swiss pharma giant Roche (ROG: SIX).

The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva/Gazyvaro plus standard therapy compared with standard therapy alone. The FDA is expected to make a decision on approval by October 2025, the company noted.