Regeneron Pharmaceuticals Inc. and Sanofi have announced the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis, a chronic and debilitating skin disease.
The FDA approval is based on data from two Phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent in adults with prurigo nodularis. A regulatory filing for prurigo nodularis is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are also planned in 2022.
“Patients living with prurigo nodularis must often contend with dozens, if not hundreds, of itchy and painful nodules covering their body and have not had an approved treatment option for their disease,” said Dr. George D. Yancopoulos, M.D., president and chief scientific officer at Tarrytown-headquartered Regeneron. “Dupixent has already transformed the treatment landscape of several diseases driven by type 2 inflammation ”“ including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis ”“ and been prescribed to more than half a million patients around the world for its approved indications. With this approval, those suffering with prurigo nodularis finally have a medicine to address the debilitating signs and symptoms of the disease.”
