approval in esophagitis in the United States

( – Sanofi announced Friday evening that the United States FDA has approved its Dupixent (dupilumab) 300 mg once weekly for the treatment of eosinophilic esophagitis in patients from the age of 12 years, weighing at least 40 kg.

With this approval, granted more than two months ahead of the FDA’s planned date, Dupixent becomes the first and only drug specifically indicated for the treatment of this disease in the United States.

In a Phase III clinical trial, Dupixent 300 mg once weekly showed significant improvement in the signs and symptoms of eosinophilic esophagitis compared to placebo.

The application for approval in this indication is currently being reviewed by the European Medicines Agency and regulatory submissions elsewhere in the world are also expected by the end of 2022.

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