Posted by Michael Wonder on 05 Mar 2025
FDA accepts supplemental biologics license application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
5 March 2025 - The filing application is based on data from the Phase 3 REGENCY study, where Gazyva/Gazyvaro showed superiority over standard therapy alone in people with active lupus nephritis.
Roche announced today that the US FDA has accepted the company’s supplemental biologics license application for Gazyva/Gazyvaro (obinutuzumab) for the treatment of lupus nephritis.
