Drug news
The FDA has rescheduled its advisory committee review of Exondys (eteplirsen) to treat Duchenne muscular dystrophy to 25 April 2016- Sarepta
The FDA has rescheduled its advisory committee review of Exondys (eteplirsen), from Sarepta, to 25 April 2016.
Comment: Sarepta has been trying to persuade the FDA that dystrophin production is the surrogate marker that can be used to support approval of Exondys (eteplirsen) to treat Duchenne muscular dystrophy (DMD) but its data submitted of walking distance of boys taking the drug was from a small trial and rejected by the FDA. New data has been submitted. There is no treatment in the US for DMD.
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