The European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.
Prurigo nodularis is a chronic, debilitating skin disease with underlying type 2 inflammation and its impact on quality of life is one of the highest among inflammatory skin diseases. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat prurigo nodularis in Europe and the U.S.
Naimish Patel, M.D., head of Global Development, Immunology and Inflammation at Sanofi, said: “As the first and only targeted medicine approved to treat people living with prurigo nodularis, Dupixent has the potential to transform the standard-of-care for people in Europe living with this debilitating skin disease.
“In the pivotal trials, patients treated with Dupixent experienced significant improvements in key hallmarks of the disease, such as reduction in itch and achieving clearer skin, as well as broader impacts on their daily lives. This approval of Dupixent underscores our continued commitment to bringing Dupixent to patients suffering from chronic skin diseases with underlying type 2 inflammation as quickly as possible.”
George D. Yancopoulos, M.D., Ph.D., president and chief scientific officer at Regeneron, said: “For the first time, patients with prurigo nodularis in Europe have a medicine that can help relieve the burden of itchy and painful nodules covering their skin, which can have a devastating impact on their day-to-day lives, both physically and mentally.
“Dupixent is now approved for its second dermatological disease and fourth disease overall. We remain committed to further investigating this innovative medicine for diseases – such as chronic urticarias and chronic obstructive pulmonary disease – in which type 2 inflammation may play a role.”
The EC decision is based on data from two Phase 3 trials, PRIME and PRIME2, evaluating the efficacy and safety of Dupixent (PRIME n=75; PRIME2 n=78) in adults with uncontrolled prurigo nodularis compared to placebo (PRIME n=76; PRIME2 n=82). In these trials, respectively, 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch at 12 weeks, compared to 16% and 22% for placebo. The improvement further increased at 24 weeks, with approximately three times as many Dupixent patients (60% and 58%) experiencing a clinically meaningful reduction in itch from baseline, compared to placebo (18% and 20%).
In PRIME and PRIME2, more than twice as many Dupixent patients (48% and 45%) also achieved clear or almost clear skin at 24 weeks, compared to placebo (18% and 16%). Dupixent also significantly improved health-related quality of life, while reducing measures of skin pain and symptoms of anxiety/depression from baseline at 24 weeks compared to placebo.
The safety results of the trials were generally consistent with the known safety profile of Dupixent in its approved indications, with the most common side effects across indications including injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. Adverse events more commonly observed in PN with Dupixent compared to placebo included conjunctivitis (4% vs. 1%).
Dupixent was granted an additional one-year marketing protection in the EU based on recommendation by the CHMP that the medicine brings significant clinical benefit compared to existing therapies for patients with prurigo nodularis.