FDA Official Signals Tough Road for Sarepta’s Shelved Duchenne Therapy Elevidys
FDA Official Signals Tough Road for Sarepta’s Shelved Duchenne Therapy Elevidys Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, Elevidys, faces a significant challenge to return to the market, according to a senior Food and Drug Administration official. The therapy was temporarily pulled due to severe safety concerns, including liver injuries linked to the deaths of two patients. Speaking anonymously to STAT, the FDA official described the path for Elevidys’ reinstatement as “arduous and treacherous,” indicating that the therapy’s license…