Sarepta, Elevidys and FDA
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Roche Holding AG said on Tuesday it has paused shipments of muscular disorder gene therapy Elevidys in some countries outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics .
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The commercial and clinical use of Elevidys was discontinued after two fatal cases of acute liver failure.
Europe's medicines regulator did not recommend the approval of Sarepta Therapeutics' gene therapy Elevidys for a type of rare muscular dystrophy, the health agency said on Friday.