EU Approves Dupixent for Young Children With Chronic Spontaneous Urticaria
The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged two to 11 years with inadequate response to antihistamines.
Sanofi and Regeneron announced that the European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in children aged two to 11 years. This marks the first approval of a targeted medicine for this age group in the EU for CSU, a chronic inflammatory skin disease causing hives and itch.
The approval allows Dupixent for children who have not responded adequately to histamine-1 antihistamines and have not previously received anti-immunoglobulin E (IgE) therapy for CSU. This expands the drug's existing indication in the EU, which already covers adults and adolescents aged 12 and older with the condition.
The decision is based on data from the LIBERTY-CUPID clinical study program. This included an extrapolation of efficacy data from adult studies, alongside pharmacokinetic, safety, and efficacy data from the CUPIDKids phase 3 study in children aged two to 11 years. The studies demonstrated that Dupixent significantly reduced urticaria activity, including itch and hives, compared to placebo.
"This approval demonstrates our commitment to extending the value of Dupixent to all who may benefit, including young children," said Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology Development at Sanofi. She noted that previous treatment options often left young patients with uncontrolled disease.
The safety profile observed in children aged two to 11 years was generally consistent with the known safety profile of Dupixent in its approved dermatological indications. Common adverse reactions in adults and adolescents with CSU included injection site reactions and conjunctivitis.