Sanofi (NYSE:SNY), the French pharmaceutical company and partner Regeneron Pharmaceuticals Inc (NASDAQ:REGN) announced that data from a phase 3 trial of their product candidate dupilumab indicates that the trial met main goals. According to trial results, Dupilumab used with Topical Corticosteroids (TCS) was superior to treatment with TCS alone. The companies plan a submission for approval by the FDA as treatment in the United States in the third quarter of this year.
Dupilumab is a monoclonal antibody designed for the treatment of skin diseases. Among the 64% of patients who received dupilumab 300 mg weekly with TCS, and 69% of patients who received dupilumab 300 mg every two weeks with TCS achieved a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS.
George D. Yancopoulos, Regeneron Chief Scientific Officer said in a statement, “These are the first long-term Phase 3 data that demonstrated dupilumab with topical corticosteroids was superior to topical corticosteroids alone, and provided sustained efficacy, significantly improving measures of overall disease severity, skin clearing, itching, and quality of life through one year of treatment.”