Prosensa agrees regulatory pathway for drisapersen with FDA
Dutch biotech Prosensa Holding (Nasdaq: RNA) saw its shares fall 5.8% to $9.98 in by close of US trading yesterday, despite revealing that the US Food and Drug Administration has outlined a regulatory path forward, under an accelerated approval pathway, for drisapersen.
This is the company's lead program for the potential treatment of Duchenne muscular dystrophy (DMD). In addition, the company has been interacting with the European Medicines Agency and based on these discussions intends to file for approval in Europe as well.
Prosensa regained all rights to drisapersen in January, when GlaxoSmithKline pulled out of a 2009 collaboration following the drug's failure to significantly improve outcomes in a six-minute walking distance test versus placebo in a late-stage study.
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