A New York panel has voted unanimously to recommend the state Medicaid program should pause coverage of a treatment for Duchenne muscular dystrophy in response to a high-profile safety controversy this past summer, a setback for Sarepta (SRPT), STAT’s Ed Silverman reports. The Drug Utilization Review Board late last week suggested the state should wait for the FDA to add safety and clinical trial data to the product labeling for the therapy, Elevidys, and the board also recommended the state should first evaluate a forthcoming regimen that the company is developing to mitigate the risk of liver failure in patients who are treated.
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