FDA has asked Sarepta Therapeutics for more data on its Duchenne muscular dystrophydrug, eteplirsen, according to CNBC. The regulator’s request could push the drug’s filing to mid-2015, rather than its originally planned date of the end of this year. FDA has requested results of up to 168 weeks from a mid-stage trial. The company reported data from up to 144 weeks in July.
FDA request delays Sarepta’s Duchenne drug
The drug is now expected to be filed by mid-2015, rather than by year's end.
