Regeneron And Sanofi Announce Japan First In The World To Approve Dupixent® For Chronic Spontaneous Urticaria

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Regeneron Pharmaceuticals, Inc.

REGN

741.29

-0.74%

Sanofi Sponsored ADR

SNY

48.68

-0.37%

Approval based on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo
CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that 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 approve Dupixent for CSU, emphasizing the value of Dupixent as a novel treatment option to manage this disease in patients with unmet needs.

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