The Japanese Ministry of Health, Labor and Welfare (MHLW) has given its approval to Sanofi for the marketing and manufacturing of Dupixent, also known as dupilumab. This drug has been approved for the treatment of chronic spontaneous urticaria in individuals aged 12 or older who have not responded adequately to existing treatments.
Japan becomes the first country to officially approve Dupixent for treating chronic spontaneous urticaria, a chronic skin inflammatory disease. The disease triggers sudden, severe hives and continuous itching due to type 2 inflammation.
This approval makes chronic spontaneous urticaria the fifth condition for which Dupixent has been approved in Japan, and it becomes the sixth condition for which the drug has received global approval.
In Japan, Dupixent is already approved for use in certain patients suffering from atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and prurigo nodularis.
Dupixent, a fully human monoclonal antibody, operates by inhibiting the signaling of interleukin-4 and interleukin-13 pathways, without functioning as an immunosuppressant.
The development of Dupilumab is a joint effort by Sanofi and Regeneron, as part of a global collaboration agreement. To date, Dupilumab has been researched across over 60 clinical trials and has involved more than 10,000 patients suffering from various chronic diseases, primarily caused by type 2 inflammation.
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