Top FDA official Peter Marks overruled staff, review team to approve Sarepta gene therapy (Jun 2024, Elevidys) Article 

Michael Harrop

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https://kffhealthnews.org/morning-breakout/despite-opposition-fda-official-oks-sareptas-duchenne-gene-therapy/
https://www.statnews.com/2024/06/20/sarepta-duchenne-elevidys-fda-approval-peter-marks-overruled-staff/

For a third time, Sarepta Therapeutics has convinced a top Food and Drug Administration official to overrule the prevailing view of their staff and approve a drug for Duchenne muscular dystrophy.

On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year.
 
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