US EditionSarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
UNITED STATES, JUL 19 – Sarepta says no new safety signals justify halting Elevidys shipments despite FDA concerns after three patient deaths linked to liver injury, with $821 million in 2024 revenue from the drug.
- Late Friday, Sarepta Therapeutics refused the FDA's request to halt shipments, following the death of a third patient linked to liver injury.
- Elevidys, the first gene therapy approved in the U.S., has faced safety scrutiny, with all three patient deaths linked to liver injury noted in prescribing information, after its June 20, 2024 approval.
- Sarepta reported $1.7 billion in net product revenue for 2024, nearly half from Elevidys, while regulators revoked approval of the AAVrh74 platform technology over safety gaps.
- Shares fell more than 35% Friday to close at $14.07, and Sarepta laid off 500 employees.
- Although the FDA has authority to withdraw drugs, Sarepta asserted ongoing safety and said `no new or changed safety signals`; it will continue shipping Elevidys to ambulant patients.
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Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died, but the company said it would not do so.
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Leaning Left12Leaning Right4Center11Last UpdatedBias Distribution44% Left
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L 44%
C 41%
15%
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