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Sanofi: eosinophilic approved in US

( - On Friday evening Sanofi announced that the US FDA has approved its Dupixent (dupilumab) 300 mg once weekly for the treatment of eosinophilic esophagitis in patients 12 years of age and older who weigh at least 40 kg.

With this approval, granted over two months ahead of schedule by the FDA, Dupixent becomes the first and only drug specifically indicated for the treatment of this disease in the US.

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

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

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