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Update from Roche regarding Delandistrogene Moxeparvovec (Elevidys)

You are here: Home / News / Update from Roche regarding Delandistrogene Moxeparvovec (Elevidys)

22 August 2025 by Mehreen Arif

On July 25th, Roche 5 the European Medicines Agency’s (EMA’s) Committee for Human Medicinal Products (CHMP) unfortunately provided a negative opinion on the marketing authorisation for delandistrogene moxeparvovec (Elevidys) in Duchenne Muscular Dystrophy (DMD) patients aged 3-7 years. Roche plans to continue dialogue with EMA to explore the path forward.

Please read the full press release to review what this means for UK and the next steps Roche is taking.

APPROVED M-GB-00023705 DMD Community Letter to PAGs EMA negative opinion_August2025.docxDownload

If you would like to talk about the topic discussed in this article, please do reach out to us at info@actionduchenne.org.

For up to date information on research, treatments and information for wherever you are in your Duchenne journey, join us at the Action Duchenne Annual International Conference 2025 on the 14th and 15th of November in Hinckley, Leicestershire!

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