Sanofi: marketing authorisation extended for Dupixent in EU
(CercleFinance.com) - Sanofi has announced that Brussels has extended the marketing authorisation (MA) for its Dupixent in the EU, making it the first and only targeted drug specifically indicated for the treatment of eosinophilic esophagitis in Europe and the United States.
The marketing authorisation for this chronic inflammatory disease is for adults and adolescents of 12 and over, who weigh at least 40 kg, and who are inadequately controlled by, intolerant to or not recommended for conventional medicines.
Approximately 60% of patients aged 12 years and older treated with Dupixent 300 mg once weekly in a pivotal trial experienced histological remission and significant improvement in swallowing ability compared to placebo.
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