Dupilumab (13) – Dupixent®

Children aged ≥ 2 years to < 12 years with moderate to severe chronic spontaneous urticaria who have an inadequate response to treatment with H1 antihistamines and who have not previously received anti-IgE antibodies as part of their CSU treatment

• For children aged ≥ 2 years to < 12 years with moderate to severe chronic spontaneous urticaria who have an inadequate response to treatment with H1 antihistamines and who have not previously received anti-IgE antibodies as part of their CSU treatment, the additional benefit compared with the appropriate comparator therapy is not proven.
• In its dossier, the pharmaceutical manufacturer has not submitted any data for the assessment of the additional benefit of dupilumab compared with the appropriate comparator therapy.
• Overall, there are therefore no data available to enable an assessment of the additional benefit of dupilumab for the treatment of moderate to severe chronic spontaneous urticaria in children aged ≥ 2 years to < 12 years with moderate to severe chronic spontaneous urticaria, who have an inadequate response to treatment with H1 antihistamines and who have not previously received anti-IgE antibodies as part of their CSU treatment.

Courtesy translation only, please refer to the German original.