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Drisapersen filed at FDA for treatment of Duchenne Muscular Dystrophy- Prosena N.V.

Read time: 1 mins
Last updated: 12th Oct 2014
Published: 12th Oct 2014
Source: Pharmawand

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.

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