Exondys Approval: FDA Commissioner's Draft Decision Drew Internal Rebuke

Even at the final step, FDA’s review of Sarepta's Duchenne muscular dystrophy drug remained collaborative and contentious, as Commissioner Califf's view that accelerated approval would not set a new precedent drew pushback from ODE I Director Unger, while Acting Chief Scientist Borio said the draft decision downplayed the 'miniscule' amount of dystrophin with eteplirsen.