Prosensa Begins NDA Submission To FDA For Exon-skipping Drug Drisapersen

(RTTNews) - Prosensa Holding N.V. (RNA) announced Friday that it has commenced the submission process for a New Drug Application or NDA regulatory filing to the United States Food and Drug Administration or FDA for its lead exon-skipping drug candidate, drisapersen, for treating Duchenne muscular dystrophy or 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.

The company said it expects the rolling submission to be completed before the end of the year, and it is on track to submitting a marketing authorization application for conditional approval with the EMA in early 2015.