Press Release: Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria

Core Insights - Dupixent (dupilumab) has been approved by the US FDA as the first new targeted therapy for chronic spontaneous urticaria (CSU) in over a decade, providing a new treatment option for patients who remain symptomatic despite antihistamine treatment [1][4][10] Company and Product Overview - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, which are key drivers of type 2 inflammation [10] - The drug is administered via subcutaneous injection, with a dosing regimen of 300 mg every two weeks for adults and adolescents over 12 years old, with weight-based dosing for younger patients [9][10] - Dupixent is already approved for CSU in several countries, including Japan, the UAE, and Brazil, with ongoing reviews in other regions such as the EU [3][12] Clinical Study Results - The FDA approval is based on data from two phase 3 clinical studies (Study A and Study C) involving 284 biologic-naïve patients aged 12 years and older, which demonstrated significant reductions in itch severity and urticaria activity compared to placebo at 24 weeks [2][6][7] - Study B provided additional safety data for patients who were inadequate responders or intolerant to anti-IgE therapy, although it did not meet its primary endpoint in the US [8][6] - The most common adverse event observed in patients treated with Dupixent was injection site reactions, consistent with its known safety profile [2][4] Market Potential - There are over 300,000 adults and adolescents in the US suffering from CSU who remain symptomatic despite antihistamine treatment, indicating a significant market opportunity for Dupixent [4][5] - Dupixent is now approved for seven chronic atopic conditions driven by type 2 inflammation, potentially benefiting patients with multiple co-morbid conditions [3][10] Development and Future Prospects - Dupilumab is being jointly developed by Sanofi and Regeneron, with over 60 clinical studies involving more than 10,000 patients conducted to date [13] - The companies are exploring additional indications for Dupixent in diseases driven by type 2 inflammation, including chronic pruritus of unknown origin and bullous pemphigoid, which are currently under clinical investigation [14]