FDA gives Prosensa's lead drug new path towards approval

[June 03, 2014]  (Reuters) - Prosensa Holding NV said the U.S. Food and Drug Administration had outlined a regulatory path for the accelerated approval of its lead drug, sending the company's shares up 15 percent in premarket trading.

The drug, drisapersen, is being developed to treat Duchenne muscular dystrophy — a muscle-wasting disorder that affects one in every 3,500 newborn boys — that has no available cure.

The Netherlands-based company said on Tuesday it planned to file an application to market the drug in the United States later this year, and would file for European approval in the near future.

Prosensa said in January it would pursue the development of drisapersen despite its failure in a late-stage trial, after additional data showed its use could slow disease progression.

Earlier that month, partner GlaxoSmithKline Plc returned the rights to the drug to Prosensa, terminating a 2009 collaboration deal to develop it.

The company's stock closed at $10.59 on the Nasdaq on Monday.

(Reporting by Natalie Grover in Bangalore; Editing by Joyjeet Das)

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