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 could potentially be revoked. The official expressed skepticism about Sarepta’s ability to demonstrate that new safety protocols could effectively mitigate the previously identified risks. “How do you show something is safe when it’s already proven to be not safe?” the official questioned, highlighting the formidable hurdle Sarepta must overcome.
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