Medicine recalls
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| The United States: FDA Investigating Death of 8-Year-Old Boy Who Received Elevidys |
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The United States (U.S.) Food and Drug Administration (FDA) announces that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy. The death occurred on June 7, 2025. The FDA has requested and received voluntary suspension of product distribution as it investigates the safety concerns.
Elevidys is an adeno-associated virus vector-based gene therapy using Sarepta Therapeutics, Inc.’s AAVrh74 Platform Technology for the treatment of Duchenne muscular dystrophy. The product is administered as a single intravenous dose. Duchenne muscular dystrophy is a rare genetic condition characterized by progressive muscular weakness. The disease occurs due to a defective gene.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-investigating-death-8-year-old-boy-who-received-elevidys
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by U.S. FDA and Singapore Health Sciences Authority, and was posted on the Drug Office website since 25 Mar 2025, with the latest update posted on 19 Jul 2025.
Ends/ Saturday, July 26, 2025
Issued at HKT 12:00
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