FDA advisory on Sarepta's eteplirsen delayed by weather

The much anticipated US Food and Drug Administration’s Peripheral and Central Nervous System Advisory Committee meeting on eteplirsen scheduled for Friday, January 22, has been postponed by the FDA due to an anticipated severe winter snowstorm forecast to hit the Washington DC area.

A future meeting date will be announced in the Federal Register. In the event of a change in the February 26, 2016 PDUFA date, the drug’s developer, Sarepta Therapeutics (Nasdaq: SRPT), says it will provide an update at that time.

The Advisory Committee was scheduled to review Sarepta’s New Drug Application for eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The NDA for eteplirsen is being reviewed under the FDA accelerated approval pathway, which allows early approval of a drug for a serious or life-threatening illness that offers a benefit over current treatments.