Posted by Michael Wonder on 26 Jul 2025
Roche provides regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy in the EU
25 July 2025 - Roche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys available to individuals living with Duchenne muscular dystrophy in the EU.
Roche announced today that the CHMP of the EMA issued a negative opinion on the conditional marketing authorisation for Elevidys (delandistrogene moxeparvovec) for ambulatory individuals aged three to seven years with Duchenne muscular dystrophy.
