Roche announces that the European Medicines Agency has validated and begun reviewing the marketing authorization application for Elevidys, to treat Duchenne muscular dystrophy in ambulatory patients aged three to seven.

This application is based on the pivotal Phase 3 EMBARK study, which confirmed that Elevidys is the first gene therapy to deliver clinically significant benefits by modifying disease progression, with a manageable safety profile.

If approved, Elevidys should be the first and only gene therapy available in Europe to treat the underlying cause of this disease. The product is already approved in the USA and several Persian Gulf countries.

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