The EU approved Dupixent for chronic hives in teens and adults unresponsive to antihistamines.

The European Commission has approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who don’t respond to antihistamines and haven’t used anti-IgE treatments. It’s the first new targeted therapy for CSU in the EU in over ten years. Approval is based on Phase 3 trial data showing significant reduction in hives and itching when Dupixent is added to antihistamines. Patients had better disease control and higher complete response rates at 24 weeks. The drug blocks IL-4 and IL-13, key drivers of inflammation. Common side effects include injection site reactions, conjunctivitis, and oral herpes. Dupixent is now approved for seven inflammatory conditions in the EU and is also available for CSU in the U.S., Japan, and other countries.