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A Strong Launch For Sarepta’s Elevidys, But Future Hinges On FDA Decision

 
• By Andrew McConaghie

Strong demand from physicians and families of boys with Duchenne has seen a rapid take-off in sales of the $3.2m gene therapy – but the FDA will have the final say on the product's future after a failed Phase III study.

Sarepta building

Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys has achieved better than expected initial sales, but its future hangs in the balance after its confirmatory Phase III study missed its primary endpoint.

The disappointing news that Elevidys (delandistrogene moxeparvovec-rokl) failed its Phase III EMBARK study was revealed on 30 October, creating uncertainty...

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