Japan first to approve Dupixent for chronic spontaneous urticaria
The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in people aged 12 years and older whose disease is not adequately controlled with existing therapy.
Japan is the first country to give an approval in the CSU indication to Dupixent, Sanofi (Euronext: SAN) and Regeneron’s (Nasdaq: REGN) interleukin (IL)-13 and IL-4 blocking antibody.
CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch. It is typically treated with histamine (H1) antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.
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