FDA accepts supplemental Biologics License Application for Roche's Gazyva/Gazyvaro for the treatment of lupus nephritis [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
The filing application is based on data from the phase III REGENCY study, where Gazyva/Gazyvaro 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 Basel, 5 March 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis. 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. “In people with lupus nephritis, Gazyva/Gazyvaro demonstrated a complete renal response benef
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