FDA grants speedy review to Sarepta’s Duchenne gene therapy

The Food and Drug Administration has started the first regulatory review of a gene therapy for Duchenne muscular dystrophy, the treatment’s developer, Sarepta Therapeutics, announced on Monday.

In a statement, Sarepta said the agency has accepted its application for an “accelerated” approval of the medicine, known as SRP-9001, and will make a decision by May 29.