FDA Accepts Application for Genentech's Gazyva for the Treatment of the Most Common Form of Lupus [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Yahoo! Finance
If approved, Gazyva would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this condition SLE is a potentially life-threatening autoimmune disease affecting more than three million people worldwide – achieving better disease control can reduce flares and may prevent irreversible organ damage SOUTH SAN FRANCISCO, Calif., April 21, 2026 BUSINESS WIRE )--Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Gazyva ® (obinutuzumab) for the treatment of systemic lupus erythematosus (SLE). The filing acceptance is based on positive results from the Phase III ALLEGORY study, which demonstrated a statistically significant and clinically meaningful benefit in the primary endpoint of SLE Responder Index 4 (SRI-4) at 52 weeks – a measure that assesses changes in diseas
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