Dupixent Gains EU Approval as First Targeted Therapy for Chronic Spontaneous Urticaria in Over a Decade

The European Commission approved Dupixent (dupilumab) on November 25, 2025, as the first targeted therapy in over ten years for moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents 12 years and older who are inadequately controlled by antihistamines and are naïve to anti-IgE therapy.1 5 6 9

This decision provides a new first-line targeted treatment option for an estimated 270,000 eligible EU patients whose CSU symptoms persist despite standard antihistamine treatment.1 6

Dupixent is a monoclonal antibody that targets key drivers of type 2 inflammation by inhibiting interleukin-4 (IL-4) and interleukin-13 (IL-13).1 2 5

Approval was based on robust data from the phase 3 LIBERTY-CUPID program (Studies A, B, and C) in which Dupixent, compared to placebo, demonstrated significant reductions in urticaria activity (itch and hives) and increased rates of well-controlled disease (UAS7 ≤6) and complete response (UAS7 = 0) at 24 weeks.1 2 11

In Study A, Dupixent-treated, omalizumab-naïve patients showed an average 20.5-point improvement in the UAS7 (Urticaria Activity Score over 7 days), versus a 12-point improvement with placebo.2

With this approval, Dupixent becomes available for CSU alongside its existing EU approvals for six other chronic, inflammatory diseases including atopic dermatitis, asthma, and eosinophilic esophagitis, reinforcing its status as a 'juggernaut' in type 2 inflammatory disease management.5 1

Dupixent can be administered as an add-on to standard antihistamine therapy, including at home after appropriate training.1