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Sarepta Eyes Patient Outcomes To Boost Exondys 51's European Review

 
• By Derrick Gingery

EMA and payers want to know more about daily life improvements from US FDA-approved Duchenne muscular dystrophy treatment.

close up of an eye

Sarepta Therapeutics Inc. is developing new patient information to potentially help gain European approval for its Duchenne muscular dystrophy treatment Exondys 51 (eteplirsen) and possibly help make headway with payers.

Controversially granted accelerated approval by FDA in September, Exondys 51 has been submitted to the European Medicines Agency for conditional approval, Sarepta CEO and CMO Edward Kaye said during a presentation and

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