Sarepta Says EU Regulators Temporarily Halt Enrollment, Dosing in Elevidys Trials

MT Newswires Live
04-04

Sarepta Therapeutics (SRPT) said Friday that recruitment and dosing in some trials of Elevidys to treat Duchenne muscular dystrophy have been temporarily suspended after EU authorities requested that the independent data monitoring committee meet to review an adverse event.

The company said the panel met on Thursday and concluded that the "overall benefit-risk profile remains favorable to continue dosing in the paused clinical trials without changes to the study protocols."

Sarepta said that it and and its partner Roche will respond to the temporary halt within a week, as requested by EU regulators.

"The subsequent decision for lifting the temporary halt will follow the EU regulatory process," Sarepta said.

Sarepta said on March 18 that a young patient in the US died of acute liver failure after receiving Elevidys. Although acute liver injury is a known potential side effect of the therapy, the company said liver failure resulting in death had not been previously reported in over 800 treated patients.

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