QuickView: Drisapersen submission is well underway
Prosensa appears set to be first to market with an exon-skipping therapy for the treatment of Duchenne muscular dystrophy (DMD). The first module of its rolling NDA (New Drug Application) for drisapersen has been submitted. Fast Track designation, coupled with an accelerated approval pathway, allows filing based on existing data with two confirmatory post-approval studies as soon as practicable. Drisapersen’s rolling submission is underway and an accelerated approval in the US is possible in Q315.
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