FDA Accepts Application for Genentech’s Gazyva for the Treatment of the Most Common Form of Lupus
ROCHE HOLDING LTD S/ADR (RHHBY)
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Source: Business Wire
Filing acceptance based on Phase III ALLEGORY data for Gazyva showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus (SLE)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 conditionSLE 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.--(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 statis
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