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Sarepta Plots Multi-Study Label Expansion For Elevidys To Eventually Cover Nearly All DMD Population

 
• By Derrick Gingery

Studies supporting label expansion already are under way, with more targeting those currently ineligible, including boys with pre-existing antibodies, set to begin later this year, after the initial accelerated approval only allowed use in four- and five-year old patients.

Dart and gene therapy
EMBARK data could be sent to the FDA before the application to expand Elevidys label is submitted. • Source: Shutterstock

Sarepta Therapeutics, Inc.’s ongoing EMBARK trial to confirm the clinical benefit of its Duchenne muscular dystrophy gene therapy Elevidys also will serve as the foundation for a substantial label expansion expected in 2024.

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• By Bridget Silverman

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