FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for Lupus

 – Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit –

– The filing application is based on data from the Phase III REGENCY study, where Gazyva showed superiority over standard therapy alone in people with active lupus nephritis –

– Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years –

https://www.businesswire.com/news/home/20250304106543/en/FDA-Accepts-Supplemental-Biologics-License-Application-for-Genentech%E2%80%99s-Gazyva-for-the-Treatment-of-Lupus-Nephritis