• Recommendation for adults and adolescents based on phase 3 studies showing Dupixent significantly reduced itch and hives at 24 weeks compared to placebo
• If approved, Dupixent would be the first targeted medicine in over a decade indicated for CSU in the EU

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the EU for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. This recommendation covers those aged 12 years and above with moderate to severe disease, with inadequate response to histamine-1 antihistamines (H1AH), and who are naive to anti-immunoglobulin E (IgE) therapy. A final decision is expected in the coming months.

The positive CHMP opinion is supported by data from two studies in the LIBERTY-CUPID phase 3 program (NCT04180488; Study A and Study C), both of which demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A third study from the LIBERTY-CUPID program, Study B, conducted in a different CSU patient population, provided additional safety data.

The safety results of the studies were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent (≥5%) than placebo in the studies of adults and adolescents with CSU were injection site reaction, COVID-19, hypertension, CSU, and accidental overdose.

Dupixent is approved for CSU in certain adults and adolescents in several countries including Japan and the US. Outside of approved jurisdictions, the safety and efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.