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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