{"id":49875,"date":"2026-04-16T11:09:08","date_gmt":"2026-04-16T11:09:08","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/49875\/"},"modified":"2026-04-16T11:09:08","modified_gmt":"2026-04-16T11:09:08","slug":"roche-to-launch-another-elevidys-trial-hoping-to-win-e-u-approval","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/49875\/","title":{"rendered":"Roche to launch another Elevidys trial, hoping to win E.U. approval"},"content":{"rendered":"

Andrew Joseph covers health, medicine, and the biopharma industry in Europe. You can reach Andrew on Signal at drewqjoseph.71.<\/p>\n

In an attempt to win European approval for the controversial medicine, Roche said Thursday it would run another trial of the Duchenne muscular dystrophy gene therapy Elevidys.\u00a0<\/p>\n

The Swiss company\u2019s move comes after European regulators last year gave a negative review<\/a> to the therapy, saying it had failed to demonstrate long-term benefits for patients with the degenerative muscle condition. Roche has rights to the therapy outside the U.S., where it is marketed by its developer, Sarepta Therapeutics.<\/p>\n

Roche said the Phase 3 trial will generate the type of evidence that could lead to a resubmission with European officials and to applications with regulatory agencies in other parts of the world. The study will evaluate the safety and efficacy of Elevidys versus placebo over 72 weeks in roughly 100 boys at the early stages of the disease.\u00a0<\/p>\n

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