PARIS (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending the approval of Dupixent (dupilumab) in the European Union for treating chronic spontaneous urticaria or CSU in adults and adolescents aged 12 years and older.
The recommendation applies to patients with moderate-to-severe disease who have an inadequate response to histamine-1 antihistamines (H1AH) and are naive to anti-immunoglobulin E (IgE) therapy. A final decision is expected in the coming months.
Dupixent is approved for chronic spontaneous urticaria in certain adults and adolescents in several countries including Japan and the United States. Chronic spontaneous urticaria is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch.
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