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Sanofi Dupixent gets European Commission nod for Prurigo Nodularis
![Sanofi Dupixent gets European Commission nod for Prurigo Nodularis Sanofi Dupixent gets European Commission nod for Prurigo Nodularis](https://medicaldialogues.in/h-upload/2022/10/28/750x450_189196-sanofi-new.webp)
Paris: Regeneron Pharmaceuticals, Inc. and Sanofi have announced that 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.
"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," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent. "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."
"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," Naimish Patel, M.D. Head of Global Development, Immunology, and Inflammation at Sanofi. "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."
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, 44% and 37% of Dupixent patients experienced a clinically meaningful reduction in itch at 12 weeks, compared to 16% and 22% for placebo, respectively. 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.
Read also: Sanofi Dupixent recommended for EU approval by CHMP for prurigo nodularis treatment
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751