- First new targeted CSU therapy approval in over 10 years, expanding market opportunity.
- Targets large market of over 300,000 eligible patients in the U.S.
- Successful Phase 3 trial results demonstrating significant efficacy.
Regeneron Pharmaceuticals (REGN, Financial) and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has given the green light to Dupixent® (dupilumab) for treating adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU), who remain symptomatic despite H1 antihistamine treatment. This approval establishes Dupixent as the first new targeted therapy for CSU in over a decade.
The FDA approval is supported by two Phase 3 clinical trials, Study A with 136 patients and Study C with 148 patients, which revealed significant reductions in itch severity and urticaria activity compared to placebo at 24 weeks. Additionally, Study B, involving 108 patients, provided safety data for those who were inadequate responders to anti-IgE therapy.
This development signifies Dupixent's seventh approved indication for conditions driven by type 2 inflammation. The treatment is set to address the needs of over 300,000 U.S. patients with CSU who continue to experience symptoms despite antihistamine treatment. The most common adverse event reported was injection site reactions.
Alyssa Johnsen, M.D., Ph.D., Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, commented, "This FDA approval provides a new treatment option to help address the underlying drivers of these severe and recurring signs and symptoms. Dupixent has the potential to improve outcomes for CSU patients who previously had limited treatment options."
Dupixent has already received approval in Japan, the United Arab Emirates (UAE), and Brazil, with ongoing regulatory reviews in other regions, including the European Union.
