Roche Pauses Commercial and Clinical Use of Elevidys
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Clinical Trials Arena on MSNSarepta and Roche halt DMD gene therapy’s use after second deathShares in both companies were down following news of the second death, casting fresh safety concerns over Elevidys.
For the second time, a person with DMD has died of acute liver failure after being treated with the one-time gene therapy Elevidys.
Following a second patient death, Sarepta is temporarily suspending use of Elevidys in non-ambulatory DMD patients, pending evaluation of an enhanced immunosuppression regimen.
Roche (SIX:ROG) shares dropped 2% on Monday after the company paused dosing of its gene therapy Elevidys in non-ambulatory patients with Duchenne muscular dystrophy following two deaths caused by acute liver failure.
A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy (DMD) gene therapy’s safety profile. | A second patient has died following treatment with Sarepta Therapeutics’ Elevidys,
Sarepta Therapeutics Inc. plummeted after reporting a second patient died of acute liver failure while being treated with its gene therapy for a rare muscle disorder.
Sarepta suspends Elevidys use in non-ambulatory Duchenne patients after two liver failure deaths, triggering FDA review and clinical trial pause.
Another person treated with Elevidys suffered acute liver failure, leading Sarepta to discontinue treatment in certain patients while it evaluates new safety precautions.
BASEL, Switzerland I June 15, 2025 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new dosing restrictions, effective immediately, for ELEVIDYS™