The European Commission has approved Dupixent (dupilumab) for treating moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and above. This approval covers patients who do not respond to H1 antihistamines and are naïve to anti-IgE therapy—making Dupixent the first targeted option available at this stage of care.
CSU is unpredictable. Patients can face sudden outbreaks of painful hives and intense itching that disrupt daily life. For many, antihistamines offer only partial relief.
Patient advocates highlight the impact.
“Dupixent is proven to reduce these intense symptoms,” said Tonya Winders, Global Allergy & Airways Patient Platform CEO.
The approval comes from the LIBERTY-CUPID Phase 3 program, which includes three randomized, placebo-controlled studies.
Participants: 284 patients (12+ years), symptomatic despite antihistamines, and anti-IgE naïve.
Dupixent delivered:
Participants: 108 patients who did not respond to or could not tolerate anti-IgE therapy.
Study B reinforced:
The results from Studies A and B were published in the Journal of Allergy and Clinical Immunology.
Across the trials, Dupixent’s safety remained aligned with previous indications.
Most common adverse reactions:
Additional reactions in CSU:
Adverse events more common than placebo included:
Injection site reaction, COVID-19, hypertension, CSU events, and accidental overdose.
Dupixent is a fully human monoclonal antibody that blocks IL-4 and IL-13 signaling.
These pathways are central drivers of type 2 inflammation, a key mechanism behind CSU and multiple related diseases.
It is not an immunosuppressant.
This mechanism makes Dupixent the only CSU therapy targeting IL-4/IL-13, according to Regeneron’s CSO, George D. Yancopoulos.
Dupixent is administered as a subcutaneous injection.
Administration can be done at home after proper training. For adolescents, adult supervision is required.
More than 270,000 people in the EU suffer from CSU that remains uncontrolled despite antihistamines. Many lack alternative treatment options.
Dupixent now gives these patients a first-line targeted therapy that can meaningfully improve symptoms and quality of life.
Dupixent is already approved for CSU in several countries, including the US and Japan.
Globally, more than 1.3 million patients are treated with Dupixent for various type-2 inflammatory diseases.
Sanofi and Regeneron continue to expand research into new indications such as: