Cardiologists voice safety concerns about Sarepta’s Elevidys

FDA’s decision to grant a new accelerated approval to Sarepta’s DMD gene therapy in a subpopulation of patients almost entirely lacking in clinical data is the latest puzzling move by the agency in the product review. And it’s led a group of prominent U.S. pediatric cardiologists to sound the alarm about the possibility of cardiovascular consequences.

Last week, FDA converted the accelerated approval of Elevidys delandistrogene moxeparvovec from Sarepta Therapeutics Inc. (NASDAQ:SRPT) in ambulatory Duchenne muscular dystrophy patients ages four and five years old to a full approval. The agency also extended the label to include all ambulatory patients aged six and older. ...