FDA Warns of Elevidys Risks, Limits Use for Duchenne Muscular Dystrophy
Update: 2025-11-14
Description
FDA Issues Serious Warnings for Gene Therapy Used in Muscular Dystrophy TreatmentThe Food and Drug Administration has announced new warnings and restrictions for Elevidys, a gene therapy used to treat Duchenne muscular dystrophy. The drug will now carry a boxed warning due to the risk of potentially fatal liver failure, following the deaths of two patients. The FDA has also limited the drugs approved use to patients aged four and older who can still walk, and recommends weekly liver function monitoring for the first three months of treatment.
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