FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
ROCHE HOLDING LTD S/ADR (RHHBY)
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Company Research
Source: Business Wire
– 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 – SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (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 plus standard therapy compared with standard therapy a
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