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Regeneron, Sanofi Announce Detailed Positive Results From Dupixent Trial

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNYNF,SNY) announced Friday detailed positive results from a pivotal Phase 3 trial evaluating Dupixent (dupilumab). The company said the data showed significant improvement in uncontrolled severe atopic dermatitis for children aged 6 to 11 years.

Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 and interleukin-13 proteins.

In the trial, Dupixent combined with standard-of-care topical corticosteroids significantly improved disease signs, symptoms and health-related quality of life in these children.

The companies will present the detailed results during a session at the 2020 Revolutionizing Atopic Dermatitis or RAD Virtual Conference on April 5. The companies previously announced topline positive results of this trial in August 2019.

The results from the Phase 3 pediatric trial are currently being reviewed by regulatory authorities, including in the U.S., EU and Canada.

Regeneron and Sanofi said the expanded Dupixent indication in children aged 6 to 11 years currently under Priority Review with the FDA; decision expected by May 26, 2020

Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.

Across all approved indications in the U.S., more than 100,000 patients have started treatment with Dupixent.

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