European regulators on Friday declared that a Duchenne muscular dystrophy gene therapy should not be approved, further imperiling the future of the treatment that is also facing increasing scrutiny in the U.S.
A European Medicines Agency committee ruled that the therapy, called Elevidys, failed to display in studies that it improved patients’ relocatement abilities. Elevidys was developed by Sarepta Therapeutics and would have been marketed in Europe by Roche.
Roche had applied for Elevidys’ approval in patients 3 to 7 years old who were still able to walk.
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