The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents. The recommendation applies to patients aged 12 years and older with moderate to severe disease who have an inadequate response to H1 antihistamines and are naive to anti-IgE therapy. A final decision from the European Commission is anticipated in the coming months.
The endorsement is backed by findings from the LIBERTY-CUPID phase 3 program (NCT04180488), including Study A and Study C, which showed that Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. An additional trial, Study B, conducted in a different CSU population, provided further safety evidence.
The safety profile observed in these studies was broadly consistent with previous indications of Dupixent. Adverse events that occurred more frequently (≥5%) with Dupixent than with placebo in adults and adolescents with CSU included injection site reactions, COVID-19, hypertension, CSU, and accidental overdose.
Dupixent is already approved for CSU in certain adult and adolescent populations in Japan and the United States. Outside of regions where approvals exist, the drug’s safety and efficacy for CSU remain under regulatory review.