Roche announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorisation (CMA) for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy (DMD). – Read More –
Given the high unmet need in DMD, Roche plans to continue to work with the EMA to explore a potential path forward.
Learn More: Roche Suspends Shipments of Elevidys Gene Therapy Outside of the United States
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