Unpredictable DMD Progression Complicates Sarepta’s Gene Therapy Efficacy Claims

As with many rare diseases, a clear natural history would make deciphering the data easier, but for now what Sarepta characterizes as stabilization is seen by FDA reviewers as expected improvement based on previous measures of disease progression at younger ages.

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FDA reviewers must decide whether uncertainty outweighs DMD patients' need for the gene therapy as soon as possible. • Source: Shutterstock

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