Results from a Phase 3 clinical trial, CHRONOS, evaluating Regeneron Pharmaceuticals (REGN -0.1%) and Sanofi's (SNY -1.4%) DUPIXENT (dupilumab), in combination with topical corticosteroids (TCS), in patients with uncontrolled moderate-to-severe atopic dermatitis (AD) showed a significant treatment benefit compared TCS alone. The data will be presented today at the Annual Meeting of the American Academy of Dermatology in Orlando, FL.
The results, first report in June 2016, showed 39% of patients treated with dupilumab + TCS achieved clear or almost clear skin at week 16 compared to 12% treated with placebo + TCS. The proportions achieving at least a 75% improvement in symptoms were 69% and 23%, respectively. The treatment benefit was sustained at week 52.
The FDA's action date for its review of the BLA is March 29. The marketing application in Europe is currently under EMA review.
Previously: Regeneron and Sanofi's dupilumab successful in late-stage atopic dermatitis study (June 6, 2016)