Europe Moves to Reject Embattled Duchenne Muscular Dystrophy Gene Therapy

Kronen Zeitung

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According to reports, after several deaths in the course of a gene therapy study with patients, the US FDA banned the delivery of a drug that had been provisionally approved in 2023 and stopped recent clinical trials. Now, a no comes from the EU. In an opinion of the European Medicines Agency EMA, it is recommended that Elevidy should not be permitted. The treatment was developed for children with Duchenne muscle dystrophy, a severe muscle weakn…

pme.ch

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The Committee for Medicinal Products for Human Use (CHMP) has recommended not granting marketing authorisation for Elevidys (delandistrogen moxeparvovec), a treatment from Basel-based giant Roche for Duchenne muscular dystrophy for patients aged 3 to 7 years.

Salzburger Nachrichten

der Standard DE

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der Standard DE

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In the U.S., the delivery of the gene therapy developed by the biotech company Sarepta and previously approved by the U.S. Department of Medicine FDA against Duchenne muscle dystrophy has been stopped after three deaths. On Thursday, the independent expert body of the EU Medicines Agency (CHMP) recommended that the treatment form should not be allowed at all, became known Friday noon.