FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis

Roche (RHHBY) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its blockbuster drug Gazvya (obinutuzumab) as a potential treatment for lupus nephritis (LN). A final decision is expected by October 2025.The sNDA is supported by data from the late-stage REGENCY study, which evaluated Gazvya plus standard therapy in LN patients. Data from the study showed that patients who were treated with Gazvya combination therapy showed a complete renal response ( ...