Japan's MHLW OKs Pfizer's CIBINQO To Treat Moderate To Severe Atopic Dermatitis

Pharma major Pfizer Inc. (PFE) on Thursday said the Japanese Ministry of Health, Labour and Welfare or MHLW has approved CIBINQO or (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies.

CIBINQO will be available in Japan in doses of 100mg and 200mg, the Manhattan-headquartered firm said.

The approval of CIBINQO in Japan was based on the results from 1,513 patients across four phase three studies, ranging from 12 to 16 weeks of treatment, and a long-term extension study from a robust clinical trial program, the company added.

Regulatory applications for abrocitinib have been submitted to countries around the world for review, including the U.S., Australia, and the EU.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted Great Britain marketing authorization for CIBINQO earlier this month.

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