Astellas shares that US FDA cleared their IND with Fast Track designation for Phase 1 trial of their investigational gene therapy for the treatment of cardiomyopathy in FA

In a communication to FARA and the FA Community, Astellas shared that the US FDA has cleared their Investigational New Drug with a fast track designation for a Phase 1 trial of their investigational gene therapy for the treatment of cardiomyopathy in patients diagnosed with FA. ASP2016 is an investigational AAV gene therapy designed to be administered via intravenous infusion to deliver a full-length functional copy of the frataxin gene to the heart of FA patients to treat cardiomyopathy associated with FA.