Sarepta Announces FDA Acceptance of Golodirsen (SRP-4053) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
Sarepta Therapeutics, Inc. (SRPT)
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Source: GlobeNewswire
-- FDA Grants Priority Review Status -- -- Regulatory Action Date is August 19, 2019 -- -- Golodirsen has been studied for the treatment of exon 53 amenable patients, approximately eight percent of patients with Duchenne -- CAMBRIDGE, Mass., Feb. 14, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, announced the Food and Drug Administration, Division of Neurology (the Division), has accepted its New Drug Application (NDA) seeking accelerated approval for golodirsen (SRP-4053) and provided a regulatory action date of August 19, 2019. Golodirsen is a phosphordiamidate morpholino oligomer engineered to treat those individuals with Duchenne muscular dystrophy (Duchenne) who have genetic mutations subject to skipping exon 53 of the dystrophin gene. Duchenne is a fatal genetic neuromuscular disorder affecting an estimated one in approximately every 3,500 - 5,000 males born worldwide. The company completed it
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