Dupilumab, a fully human monoclonal antibody, received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) to treat moderate to severe atopic dermatitis in adults for whom topical prescriptions do not work or are not an option. Co-developed by Regeneron and Sanofi, dupilumab blocks signaling from IL-4 and IL-13—the key cytokines responsible for the Th2 immune response that is understood to be a crucial pathway in allergic inflammation. It’s also being evaluated for the treatment of asthma and chronic sinusitis with nasal polyposis.
The FDA’s Breakthrough Therapy designation expedites the development and review of serious or life-threatening illnesses. Dupilumab’s safety and efficacy is still being investigated and evaluated. For more information on the Phase 3 clinical trial, visit http://clinicaltrials.gov.