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New Indication Alert: Japan’s MHLW grants approval for Dupixent® (dupilumab) to Treat Chronic Spontaneous Urticaria

Feb 16, 2024

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy.  Approval followed a phase 3 trial showing Dupixent® significantly reduced itch severity compared to placebo.  

Last month, FDA approved a new indication of Dupixent® (dupilumab) for the treatment of paediatric patients with eosinophilic esophagitis.