PARIS (dpa-AFX) - 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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