Sanofi's Dupixent Approved In Japan For Chronic Spontaneous Urticaria Treatment

(RTTNews) - The Ministry of Health, Labor and Welfare or MHLW in Japan has granted marketing and manufacturing authorization for Dupixent or dupilumab for the treatment of chronic spontaneous urticaria in people aged 12 years and older whose disease is not adequately controlled with existing therapy, Sanofi (SNYNF) said in a statement.

Japan is the first country to approve Dupixent for chronic spontaneous urticaria (CSU). CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and persistent itch.

CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for Dupixent globally.

In addition to CSU, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

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