Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

The Breakthrough Therapy designation was based on positive results from Phase 1 and Phase 2 clinical trials. Currently a Phase 3 clinical program for dupilumab in adults with moderate-to-severe atopic dermatitis is ongoing.

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Dupilumab is a fully human monoclonal antibody directed against the shared IL-4 receptor alpha subunit, which blocks signaling from both IL-4 and IL-3.

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