FDA, Sarepta Therapeutics
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Sarepta Therapeutics Inc. announced that the company plans to temporarily pause all shipments of its gene therapy to treat Duchenne muscular dystrophy, Elevidys, in a reversal of its prior stance.
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.
Roche Holding AG has temporarily halted shipments of the gene therapy Elevidys in some countries outside the U.S. following a similar move by U.S. partner Sarepta Therapeutics. The decision comes after the FDA requested a pause following the death of a patient undergoing the treatment.
Shipments will halt by close of business Tuesday evening, the company said. Sarepta had initially rejected the agency’s request, which was issued Friday.
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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.
The head of the US Food and Drug Administration said the agency will “take a hard look” at a gene therapy from Sarepta Therapeutics Inc. after two patient deaths, adding pressure to the biotech company which also announced a third patient had recently died on a similar treatment.
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.
Sarepta faces FDA scrutiny over Elevidys as analysts downgrade stock and warn of long-term debt risks amid market uncertainty.