US FDA delays decision on Sarepta Therapeutics’ drug to treat muscular dystrophy

The company said that it was informed by FDA that it will require another three months to complete its New Drug Application (NDA) review for eteplirsen.

Sarepta received a notice about the same from the FDA, saying that the Prescription Drug User Free Act (PDUFA) date for eteplirsen has been extended up to 26 May, 2016.

The rescheduled meeting date for Peripheral and Central Nervous System Advisory Committee has not yet been announced.

Sarepta’s submission of 4 year clinical effectiveness data has been designated as a major amendment to the NDA.

According to FDA, the PDUFA goal date has been extended for three months to allow for a detailed review of the submission.

Sarepta’s interim chief executive officer and chief medical officer, Edward Kaye said: "While our primary goal is to bring treatment to patients with Duchenne as quickly as possible, we appreciate the efforts of the FDA to conduct a complete review of all of the data supporting our NDA and we remain committed to working closely with them throughout the remainder of the regulatory process."

Sarepta’s drug eteplirsen was previously given priority review status. This status is given to those drugs where no other treatment or therapy is available.

The FDA also granted eteplirsen Rare Pediatric Disease Designation as well as Orphan Drug Designation and Fast Track Status