Robert Califf, FDA commissioner (Jose Luis Magana/AP Images)
Fourth accelerated approval in Duchenne? Sarepta gets priority review for gene therapy amid FDA scrutiny
Sarepta is once again on the accelerated approval path for a Duchenne drug, picking up a priority review Monday morning.
The FDA granted the accelerated review to SRP-9001, Sarepta announced Monday, which would become the biotech’s fourth Duchenne drug if approved. Much like SRP-9001 will do, each of the previous three therapies went through the accelerated approval pathway. But unlike the others, SRP-9001 is a gene therapy.
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