Wedoany.com Report-Nov. 27, The European Commission has approved Dupixent (dupilumab), developed by Regeneron and Sanofi, for treating moderate-to-severe chronic spontaneous urticaria (CSU) in patients aged 12 years and older. This marks the first new targeted therapy for the condition in Europe in over ten years.

The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, on the outskirts of Copenhagen, Denmark, November 24, 2025.

Eligible patients are those whose symptoms remain inadequately controlled by H1 antihistamines and who have not previously received anti-IgE treatment. CSU is a chronic inflammatory skin condition characterized by recurrent hives and intense itching.

Regeneron’s chief scientific officer George Yancopoulos said: “Physicians now have a new approach for CSU with Dupixent, as the only treatment that inhibits IL-4 and IL-13, two key drivers of type 2 inflammation, and can offer patients significant improvement in debilitating itch and hives.”

The approval is supported by results from the Phase III LIBERTY-CSU CUPID study, which showed that Dupixent, when added to standard antihistamine therapy, significantly reduced itch and hive severity over 24 weeks compared with antihistamines alone.

Approximately 270,000 people aged 12 and older in the European Union live with CSU that responds poorly to antihistamines. Dupixent provides a new treatment option for this population.

The medicine becomes the second targeted therapy approved in Europe for antihistamine-refractory CSU, following omalizumab, which was authorized in 2014.

Dupixent previously received approval for the same CSU indication from the U.S. Food and Drug Administration in April 2025.

In Europe, Dupixent is already authorized for multiple type 2 inflammatory conditions, including atopic dermatitis, asthma, and eosinophilic esophagitis. The drug continues to show strong commercial performance, with third-quarter sales reaching €4.2 billion, a 26.2 percent increase year-on-year—the first time quarterly sales exceeded €4 billion.

Global forecasts project Dupixent to achieve annual sales of $25.4 billion by 2031, reflecting sustained demand across its expanding range of indications. The CSU approval further strengthens its position as a leading therapy in chronic inflammatory diseases.