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Sarepta CEO Vows To Get Exondys 51 Into EU Despite CHMP Negative Trend Vote

 
• By Sten Stovall

CEO Doug Ingram aims to change EMA panel's view with a re-review, but concedes that EU arrival of the controversial DMD drug will now take longer than first thought.

DMD
Sarepta’s DMD Drug Eteplirsen Has Been Rebuffed By European Regulatory Advisors • Source: Shutterstock

Sarepta Therapeutics Inc.’s plans to get its drug Exondys 51 (eteplirsen) approved in Europe this year have been derailed by regulatory advisors there, but the Boston, Mass.-based biotech's CEO has vowed to do what it takes to get the proposed treatment for Duchenne muscular dystrophy (DMD) re-assessed - and ultimately launched - on the European market.

Sarepta used its first-quarter earnings update on May 3 to announce that it received a negative trend vote following its oral presentation to the European Medicines Agency panel, the Committee...

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