FDA gives Prosensa's lead drug new path towards approval

June 3 Tue Jun 3, 2014 7:52am EDT

June 3 (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.

Prosensa shares were 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 Dutch company said on Tuesday it planned to file an application to market the drug in the United States later this year. (Reporting by Natalie Grover in Bangalore; Editing by Joyjeet Das)

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