Shares of Sarepta Therapeutics jumped more 29% after a prominent critic of the company’s Duchenne muscular dystrophy drug left the U.S Food and Drug Administration.
The drug eteplirsen has been discussed by people who biotechnology news as patient groups and parents have been arguing in favor of the drug, pressuring federal regulators to approve it. Dr. Ronald Farkas has been a critic of the drug. On the previous review of the drug Dr. Farkas claimed that the clinical trial results showed no proof that progression of the disease was slowed down, as Sarepta claims.
On Wednesday the FDA confirmed that Dr. Ronald Farkas no longer works at the agency. No details about Farkas's departure were provided.
Duchenne muscular dystrophy is a rare genetic disorder which causes muscular weakness and is caused by a lack of the crucial protein dystrophin needed for healthy muscles. Eteplirsen is designed to increase the production of dystrophin in the body of patients, by this weakening the symptoms of the disorder.
In June, the FDA asked Sarepta for additional data after the agency delayed its highly anticipated decision on whether to approve the drug.