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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 Q...
QuickView: Drisapersen NDA submission under way
Prosensa has submitted the first module (>15,000 pages) of its rolling NDA (New Drug Application) for drisapersen for the treatment of Duchenne muscular dystrophy (DMD). Fast Track designation, coupled with the positive feedback from the FDA for an accelerated approval pathway, allows filing based on existing data with two confirmatory post-approval studies as soon as practicable. The rolling submission should be completed before end-2014, with a European submission likely in early-2015.
QuickView: FDA outlines regulatory approval pathway
The FDA has outlined a regulatory path, based on existing clinical data, for drisapersen in Duchenne muscular dystrophy (DMD). US filing is expected later this year and will be conditional on the commitment to perform two confirmatory studies post-approval. Prosensa already has 450 patient years of data on more than 300 individuals, which suggest that drisapersen has most effect when treatment is initiated earlier in the disease or continued for longer periods. Prosensa has €77m cash (March 20...
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