FDA panel to discuss Sarepta DMD trial

FDA’s Pediatric Advisory Committee and Pediatric Ethics Subcommittee are to meet on May 18 to discuss the use of drug ports in the ongoing Phase III ESSENCE trial evaluating two therapies from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to treat Duchenne muscular dystrophy.

Sarepta is seeking to modify the trial to use drug ports, rather than IV infusions, as the delivery mode of exon-skipping therapies SRP-4045 and SRP-4053 in patients aged seven to 13...