Sarepta Therapeutics, FDA
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After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.
Roche Holding AG said on Tuesday it has paused all shipments of muscular disorder gene therapy Elevidys outside the U.S., echoing a similar decision by U.S. partner Sarepta Therapeutics on Tuesday.
The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still walk. A pause on shipments to older, non-ambulatory patients remains in place.
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GlobalData on MSNSarepta halts Elevidys shipments following FDA pressureSarepta CEO Doug Ingram said it is important the company maintains a “positive working relationship” with the FDA.
Sarepta Therapeutics said it will voluntarily “and temporarily” pause all shipments of Elevidys® (delandistrogene moxeparvovec-rokl), the marketed Duchenne muscular dystrophy (DMD) treatment linked to the deaths of two patients this year.
A standoff over Elevidys could have major consequences for Duchenne patients, gene therapy companies and the perception of the FDA.