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At least 18 PDUFA dates on FDA’s calendar for May
The decisions include Sarepta’s DMD candidate, which could become the first gene therapy to receive accelerated approval
May 3, 2023 1:05 AM UTC
Among the 18 PDUFA dates scheduled for May is an application seeking the first accelerated approval of a gene therapy.
Partners Sarepta Therapeutics Inc. (NASDAQ:SRPT) and Roche (SIX:ROG; OTCQX:RHHBY) are seeking accelerated approval of delandistrogene moxeparvovec (SRP-9001) to treat Duchenne muscular dystrophy based on microdystrophin expression and limited functional data. Last month, Peter Marks, director of FDA’s Center for Biologics Evaluation and Review, listed opening of the accelerated approval pathway to gene therapies among the center’s priorities...