Sanofi and Regeneron Pharmaceuticals Inc. announced that detailed results from two placebo-controlled Phase 3 studies evaluating investigational Dupixent (dupilumab) in adult patients with inadequately controlled moderate-to-severe atopic dermatitis (AD), were published in The New England Journal of Medicine (NEJM).
The studies met their primary endpoints evaluating extent and severity of the disease. In addition, both trials met key secondary endpoints measuring reduction in itch, improvement in patient-reported anxiety and depression symptoms, and certain quality of life measures.
For the 16-week treatment period, the overall rate of adverse events (65-73 percent Dupixent and 65-72 percent placebo) was comparable between the Dupixent groups and the placebo groups. The proportion of patients who completed the treatment period was 88-94 percent for Dupixent and 80.5-82 percent for placebo.
The Dupixent Biologics License Application (BLA) was recently accepted for Priority Review by the U.S. Food and Drug Administration (FDA) with a target action date of March 29, 2017. The FDA granted Dupixent Breakthrough Therapy designation in uncontrolled moderate-to-severe atopic dermatitis in 2014. The European Medicines Agency (EMA) and FDA have conditionally accepted Dupixent as the trade name for dupilumab.