US EditionFDA Gives the Go-Ahead to Restart Elevidys Shipments
UNITED STATES, JUL 27 – FDA concluded the latest patient death was unrelated to Elevidys and approved resuming shipments for ambulatory Duchenne patients after a rapid safety review, Sarepta said.
- The FDA lifted its voluntary pause and authorized Sarepta to resume Elevidys shipments for ambulatory Duchenne muscular dystrophy patients after a safety review in mid-2025.
- This pause followed safety concerns and three patient deaths, including an investigation of an 8-year-old boy in Brazil who was treated with Elevidys but was deemed unrelated to the therapy by authorities.
- Elevidys is a single-dose intravenous gene therapy indicated for patients aged four and older with Duchenne muscular dystrophy, with common side effects including vomiting, liver injury, pyrexia, and thrombocytopenia.
- Sarepta CEO Doug Ingram expressed satisfaction with the FDA's prompt evaluation, highlighting it as a sign of dedication to the Duchenne community, while patient organizations welcomed the quick conclusion of the investigation.
- The resumption applies only to ambulatory patients, with a voluntary hold remaining on non-ambulatory patients as Sarepta works with the FDA on enhanced safety measures and labeling.
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Leaning Left2Leaning Right2Center2Last UpdatedBias Distribution33% Left, 33% Center, 33% Right
Bias Distribution
- 33% of the sources lean Left, 33% of the sources are Center, 33% of the sources lean Right
33% Right
L 33%
C 33%
R 33%
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