Coalition Duchenne Says FDA Panel Missed ‘Complexity’ of DMD in Vote Against Eteplirsen
An expert panel convened by the U.S. Food and Drug Administration (FDA) recently voted against granting accelerated approval to the novel Duchenne muscular dystrophy (DMD) drug candidate, eteplirsen. The vote came after a review of clinical trial data and 11 hours of hearing testimony that focused on the drug’s efficacy,…