Globenewswire·2025-09-22 04:30Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and above who have moderate to severe disease and inadequate response to histamine-1 antihistamines [1][2] Group 1: Clinical Data and Efficacy - Dupixent demonstrated significant reduction in itch and hives at 24 weeks compared to placebo in two studies from the LIBERTY-CUPID phase 3 program [2][10] - A third study provided additional safety data for Dupixent in a different CSU patient population [2] Group 2: Safety Profile - The safety results were consistent with Dupixent's known safety profile, with common adverse events including injection site reactions, COVID-19, hypertension, CSU, and accidental overdose [3] Group 3: Current Approvals and Market Presence - Dupixent is already approved for CSU in certain adults and adolescents in multiple countries, including Japan and the US [4][7] - The drug has received regulatory approvals in over 60 countries for various indications, with more than one million patients currently being treated globally [7] Group 4: Background on CSU and Dupixent - Chronic spontaneous urticaria (CSU) is a chronic inflammatory skin disease often inadequately controlled by standard treatments, leaving patients with limited options [5] - Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling pathways, addressing type 2 inflammation [6] Group 5: Ongoing Research and Future Indications - Sanofi and Regeneron are exploring Dupixent for additional diseases driven by type 2 inflammation in ongoing phase 3 studies [9]