Drug news
Drisapersen filed at FDA for treatment of Duchenne Muscular Dystrophy- Prosena N.V.
Prosensa Holding N.V. (RNA) has announced that it has commenced the submission process for a New Drug Application (NDA) regulatory filing to the FDA for its lead exon-skipping drug candidate, drisapersen, for treating Duchenne Muscular Dystrophy (DMD). The drug received "Fast Track status" from the FDA, making it eligible for a rolling review of an NDA and was also granted "Breakthrough Therapy Designation" in June 2013.