Advisory Committee Meeting for SRP 9001 for Duchene Muscular Dystrophy will be May 12, 2023
Sarepta Therapeutics, Inc. the leader in precision genetic medicine for rare diseases, announced that the date of the FDA' s Cellular, Tissue and Gene Therapies Advisory Committee meeting for the SRP-9001 (delandistrogene moxeparvovec) biologics license application (BLA) is May 12, 2023
The advisory committee meeting will be hosted as a virtual meeting. SRP 9001 is Sarepta’s investigational gene therapy for the treatment of Duchenne muscular dystrophy.
About SRP 9001 (delandistrogene moxeparvovec); SRP 9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy intended to deliver SRP 9001 to muscle tissue for the targeted production of functional components of dystrophin. Sarepta is responsible for global development and manufacturing for SRP 9001 and plans to commercialize SRP 9001 in the United States upon receiving FDA approval. In December 2019, Roche partnered with Sarepta to combine Roche’s global reach, commercial presence and regulatory expertise with Sarepta’s gene therapy candidate for Duchenne to accelerate access to SRP 9001 for patients outside the United States.