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