ARTICLE | Company News
Sarepta's eteplirsen gets Priority Review
August 26, 2015 2:05 AM UTC
Sarepta Therapeutics Inc. (NASDAQ:SRPT) said FDA accepted and granted Priority Review to NDA for eteplirsen ( AVI-4658) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The PDUFA date is Feb. 26, 2016.
FDA granted eteplirsen rare pediatric disease designation last week. The phosphorodiamidate morpholino oligomer (PMO) targeting exon 51 also has Orphan Drug designation in the U.S. and EU and Fast Track designation in the U.S. to treat DMD (see BioCentury Extra, Aug. 21). ...