TARRYTOWN, N.Y. & PARIS — November 25, 2025. The European Commission has granted landmark approval for Dupixent® (dupilumab) as the first targeted therapy in more than ten years for moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who remain symptomatic despite antihistamines and are naïve to anti-IgE treatment. This major regulatory milestone, backed by compelling Phase 3 data, transforms the therapeutic landscape for more than 270,000 EU patients whose CSU remains uncontrolled by current standard-of-care options.
Science Significance
The approval of Dupixent reflects a profound advance in understanding and targeting type 2 inflammatory diseases. By inhibiting IL-4 and IL-13, two central drivers of type 2 inflammation, Dupixent offers a precise mechanism that significantly reduces itch intensity, hive burden, and overall urticaria activity. In Phase 3 studies from the LIBERTY-CUPID program, Dupixent delivered statistically significant improvements at 24 weeks, enhancing rates of well-controlled disease and complete response compared to antihistamines alone. These results extend Dupixent’s scientific leadership across seven chronic inflammatory disorders in the EU, reinforcing its role as a powerful biologic capable of reshaping immune-mediated disease management.
Regulatory Significance
The European Commission’s decision follows rigorous evaluation of three randomized, double-blind, placebo-controlled trials—Studies A, B, and C—demonstrating strong efficacy and a safety profile consistent with existing Dupixent indications. Across trials, Dupixent showed clear benefit in reducing UAS7 itch–hive scores, improving itch severity, and increasing the proportion of patients achieving UAS7 ≤6 and UAS7 = 0. This approval marks the first major regulatory innovation in CSU in over a decade, providing physicians with a first-line targeted biologic for eligible patients. The streamlined assessment underscores regulators’ growing confidence in therapies addressing type 2 inflammatory pathways.
Business Significance
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For Sanofi and Regeneron, Dupixent remains a cornerstone biologic, now treating over 1.3 million patients globally across multiple approved indications. The new CSU approval strengthens Dupixent’s commercial trajectory in the highly competitive immunology market, expanding its reach to a large population with few effective treatment alternatives. As CSU remains uncontrolled in many antihistamine-treated patients, this approval opens a new revenue pathway and enhances Dupixent’s position as a market-defining, multi-indication franchise. The decision reinforces investment confidence in the broader Dupixent development program, which spans more than 60 trials and 10,000 patients.
Patients’ Significance
CSU patients frequently endure debilitating, unpredictable cycles of itch and hives, causing sleep disruption, emotional distress, and reduced quality of life. Many receive limited relief from antihistamines, leaving them with prolonged disease activity and few alternatives. With this approval, eligible patients can now access a proven first-line targeted therapy that showed clear symptom reduction and meaningful improvements in disease control. New evidence from two Phase 3 studies confirms that Dupixent can significantly reduce flare severity, improve daily functioning, and help patients regain stability in a disease known for unpredictability and chronic burden.
Policy Significance
The EU’s endorsement of Dupixent aligns with broader health-policy goals to enhance access to effective, evidence-based biologics for chronic inflammatory conditions. Better CSU control can reduce emergency visits, long-term antihistamine dependence, and productivity loss linked to recurring flare cycles. Policymakers increasingly recognize the cost-effectiveness of therapies that deliver sustained symptom reduction and improve patient well-being. This approval positions Dupixent for inclusion in national reimbursement discussions and updated CSU treatment guidelines, supporting equitable access across EU member states and strengthening the public-health response to chronic inflammatory diseases.
The approval of Dupixent as the first targeted therapy for CSU in more than a decade represents a decisive shift in the management of a long-neglected chronic inflammatory disorder. Backed by strong Phase 3 evidence, a consistent safety profile, and established immunologic precision, Dupixent offers clinicians and patients a powerful new option for reducing itch, hives, and overall disease burden. As Sanofi and Regeneron expand Dupixent’s reach, this milestone marks a transformative step in advancing immunology therapeutics across Europe and elevating standards of care for CSU patients.
Source: Regeneron Pharmaceuticals, Inc. press release
