European Medicines Agency recommends Dupixent for adults with prurigo nodularis
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The European Medicines Agency has recommended the approval of Dupixent in the European Union for adults with moderate to severe prurigo nodularis, Regeneron Pharmaceuticals and Sanofi announced in a press release.
The recommendation from the agency’s Committee for Medicinal Products for Human Use is specifically for adults with prurigo nodularis who are candidates for systemic therapy.
Prurigo nodularis, a chronic skin disease with underlying type 2 inflammation, has a high impact on quality of life, according to the press release. Those with prurigo nodularis can experience intense, persistent itching and develop thick skin lesions that can cover most of the body.
The recommendation was supported by data from two phase 3 trials, PRIME and PRIME2, in which Dupixent (dupilumab) significantly reduced itch and skin lesions compared with placebo. According to the press release, the safety results of the trial were consistent with the drug’s known safety data across its approved indications, and patients reported reduced measures of skin pain and symptoms of depression, indicating an improved quality of life.
Dupixent, a fully human monoclonal antibody, is currently approved for certain patients of different ages with prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps or eosinophilic esophagitis. It is approved across all indications in the U.S. and for certain indications in more than 60 countries.
The European Medicines Agency expects to make a final decision regarding the Dupixent application in the coming months, according to the press release.
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