EU drug panel recommends Dupixent for kids 2–11 with severe hives unresponsive to antihistamines.

The European Medicines Agency’s CHMP has recommended expanding Dupixent’s approval to treat children aged 2 to 11 with moderate-to-severe chronic spontaneous urticaria who haven’t responded to antihistamines and haven’t received anti-IgE therapy. The recommendation follows its 2025 EU approval for patients 12 and older. The European Commission is expected to make a final decision soon. Dupixent, a biologic targeting immune pathways, generated $18.5 billion in global sales in 2025.