FDA restricts Elevidys label – adds boxed warning for DMD gene therapy

Regulatory reporting from BioCentury indicates the FDA has moved to restrict the label and add a boxed warning to Sarepta’s microdystrophin gene therapy Elevidys. The label change responds to physician concerns raised after the therapy’s accelerated approval, reflecting closer post‑approval safety scrutiny of systemically delivered AAV gene therapies. The agency’s action may affect prescribing practices, risk‑management requirements and monitoring expectations for other AAV‑based systemic gene therapies under review or on market.