FDA postpones panel meeting to review Sarepta’s DMD drug

(Reuters) – The U.S. Food and Drug Administration postponed a meeting of its advisory panel to review Sarepta Therapeutics Inc’s drug for a rare muscle wasting disorder due to inclement weather forecast for Washington DC.

Sarepta’s shares were down nearly 3 percent at $12.90 in extended trading.

The date of the meeting, which was scheduled for Friday, will be announced later, the FDA said.

Sarepta’s drug, eteplirsen, is designed to treat a subset of patients with Duchenne muscular dystrophy (DMD), which hampers muscle movement and affects one in 3,600 newborn boys, with most patients dying by the age of 30.

There are no FDA-approved drugs for DMD, and pressure has been mounting on the FDA to swiftly approve treatments.

The FDA’s staff said on Jan. 15 that they were unconvinced about eteplirsen’s efficacy and trial design, a day after the regulator rejected a rival drug, Kyndrisa, developed by BioMarin Pharmaceutical Inc.

(Reporting by Rosmi Shaji in Bengaluru)

• Health
• Pharmaceuticals Drug Trials
• Food and Drug Administration
• Sarepta Therapeutics