Sarepta Pursues DMD Gene Therapy Accelerated Approval To Be First To Market

New Data Analyses Swayed US FDA To Allow Early Filing

Sarepta has experience pursuing accelerated approvals in the US for Duchenne muscular dystrophy therapies, but with a costly gene therapy will payers require data from a controlled Phase III study?

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Sarepta hopes to fast-track SRP-9001 to DMD patients • Source: Shutterstock

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