Sanofi and Regeneron announce that dupilumab has received FDA breakthrough therapy designation in atopic dermatitis

FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis that are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate. Dupilumab is an investigational therapy blocking IL-4 and IL- 13, two cytokines required for the Th2 immune response. The designation is based on previously announced positive results from Phase 1 and 2 clinical trials.

For more details, go to: http://en.sanofi.com/Images/37639_20141120_Dupilumab_AD_Breakthrough_2_en.pdf

Michael Wonder

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Michael Wonder

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