ARTICLE | Clinical News

Catena idebenone regulatory update

September 7, 2015 7:00 AM UTC

Santhera said FDA granted rare pediatric disease designation to idebenone to treat Duchenne muscular dystrophy (DMD). Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, upon approval of an NDA or BLA for a rare pediatric disease, the sponsor would be eligible for a transferrable Priority Review voucher for a subsequent NDA or BLA. This year, Santhera plans to submit a rolling NDA to FDA and a regulatory application to EMA for idebenone to treat DMD. Santhera said it will request Priority Review for the NDA. ...