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Sarepta Will Challenge Expected No From EMA On Exondys 51

 
• By Sten Stovall

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

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Sarepta’s DMD Drug Eteplirsen Has Been Rebuffed by European Regulators • Source: Shutterstock

Sarepta Therapeutics Inc. is planning to appeal the expected knock-back of its EU marketing authorization application (MAA) for the controversial drug eteplirsen.

A negative opinion on the MAA from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is expected later this month. The subsequent re-examination of the opinion...

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