PARIS (dpa-AFX) - Sanofi (SNY, SNYNF, SAN.PA) and Regeneron Pharmaceuticals Inc. (REGN) announced that the European Commission has approved Dupixent (dupilumab) as a first-line targeted treatment for moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who do not respond adequately to histamine-1 antihistamines (H1AH) and are naïve to anti-immunoglobulin E (IgE) therapy.
Dupixent is also approved for chronic spontaneous urticaria in certain adults and adolescents in several countries including the US and Japan.
Chronic spontaneous urticaria or CSU is a chronic, inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1AH, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite H1AH treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life.
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