Globenewswire·2025-11-25 06:00Core Insights - The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in patients aged 12 years and older who do not respond adequately to standard antihistamine treatment [1][4][11] - Dupixent is the first innovative treatment for CSU in over a decade, targeting IL-4 and IL-13, which are key drivers of type 2 inflammation [2][4] - The approval is based on data from two Phase 3 clinical trials showing significant reductions in itch and hives compared to placebo at 24 weeks [1][2][7] Group 1: Approval and Indications - Dupixent is now approved for use in patients with CSU who are naïve to anti-immunoglobulin E (IgE) therapy and have inadequate responses to histamine-1 antihistamines [1][4] - Approximately 270,000 adults and adolescents in the EU suffer from CSU that remains symptomatic despite standard treatment [1][6] Group 2: Clinical Trials and Efficacy - The LIBERTY-CUPID Phase 3 program included three studies assessing Dupixent as an add-on therapy to antihistamines, demonstrating significant efficacy in reducing urticaria activity and improving patient outcomes [2][7][8] - Study A and Study C involved 284 patients aged 12 years and older, while Study B included 108 patients, providing additional safety data [2][7] Group 3: Safety Profile - Safety results from the trials were consistent with Dupixent's known safety profile, with common adverse reactions including injection site reactions, conjunctivitis, and arthralgia [3][4] - Adverse events observed more frequently with Dupixent compared to placebo included injection site reactions, COVID-19, and hypertension [3][4] Group 4: Broader Context and Future Potential - Beyond the EU, Dupixent is also approved for CSU in the United States and Japan, indicating a growing acceptance of the treatment in various markets [4][11] - The Dupixent development program has been extensive, with over 60 clinical trials involving more than 10,000 patients across various chronic diseases driven by type 2 inflammation [15][16]