Sarepta Therapeutics has asked the Food and Drug Administration to approve its gene therapy for Duchenne muscular dystrophy under accelerated review, the company said Thursday.
The biotechnology company’s application for SRP-9001, also known as delandistrogene moxeparvovec, is primarily based on biological data — specifically the ability of the gene therapy to boost production of a form of the protein that’s missing in Duchenne patients.
