The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Dupixent (dupilumab) to treat chronic spontaneous urticaria (CSU) in adults and adolescents.
The recommendation applies to patients aged 12 and older with moderate to severe CSU who do not respond to H1 antihistamines and have not received 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 III programme, both of which demonstrated that Dupixent significantly reduced itch and hives at 24 weeks compared to placebo.
A third study from the LIBERTY-CUPID programme, 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 or efficacy of Dupixent for CSU has not been fully evaluated by any regulatory authority.