European Commission approves Dupixent, first targeted treatment for prurigo nodularis
The European Commission has approved Dupixent for the treatment of moderate to severe prurigo nodularis in adults who are candidates for systemic therapy in the European Union, Regeneron and Sanofi announced in a press release.
This approval follows the European Medicines Agency’s recommendation in November and makes Dupixent (dupilumab), a fully human monoclonal interleukin (IL)-4 and IL-13 inhibitor, the first and only targeted medicine specifically indicated to treat prurigo nodularis in Europe. In September, the FDA approved Dupixent for the same indication in the United States.
“For the first time, adults in the [European Union] with prurigo nodularis have a targeted medicine that addresses an underlying cause of the disease,” Bola Akinlade, MD, MBA, FACP, senior vice president of clinical development, immunology and inflammation at Regeneron, told Healio.
“Patients until now had to rely on high-potency topical corticosteroids, which may have safety risks if used long term,” Akinlade continued. “In clinical trials, Dupixent not only reduced key hallmarks of this disease... but also improved important aspects of prurigo nodularis that negatively impact patients’ daily lives.”
The approval was supported by data from two phase 3 trials, PRIME and PRIME2, in which patients taking Dupixent vs. placebo saw a significant reduction in itch at week 24 (60% and 58% vs. 18% and 20%, respectively). In addition, a greater proportion of Dupixent patients saw an improvement to clear or almost clear skin at 24 weeks compared with those taking placebo (48% and 45% vs. 18% and 16%).
According to the press release, the safety results of the trials 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.
“This is the first time a therapy has been effective in treating this population of patients,” Naimish Patel, MD, senior vice president and head of global development for immunology and inflammation at Sanofi, told Healio. “This approval gives providers a targeted option for adults with moderate to severe [prurigo nodularis] who otherwise would have no options.”