FDA calls for dystrophin data prior to making eteplirsen NDA decision

US RNA-based drug developer Sarepta Therapeutics (Nasdaq: SRPT) says that the US Food and Drug Administration has requested additional data relating to its regulatory approval for its much delayed Duchenne muscular dystrophy drug candidate.

The FDA has asked Sarepta to provide dystrophin data, as measured by western blot, from biopsies already obtained from the ongoing confirmatory study of eteplirsen (Promovi), as part of its ongoing evaluation of the eteplirsen New Drug Application (NDA).

An FDA advisory committee in April voted against accelerated approval for eteplirsen. The decision was due to be made on May 16, but it has now been delayed by the FDA, which has not provided any indication on when a decision might be due.