1 October 2021 - - The Japanese Ministry of Health, Labour and Welfare has approved Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 inhibitor, for the treatment of moderate to severe atopic dermatitis in adults and adolescents aged 12 years and older with inadequate response to existing therapies, US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) said.

Cibinqo will be available in Japan in doses of 100mg and 200mg.

The approval of Cibinqo in Japan was based on the results from 1,513 patients across four Phase 3 studies, ranging from 12 to 16 weeks of treatment, and a long-term extension study from a robust clinical trial program.

Regulatory applications for abrocitinib have been submitted to countries around the world for review, including the United States, Australia, and the European Union.

The UK Medicines and Healthcare products Regulatory Agency granted Great Britain marketing authorization for Cibinqo earlier this month.

Cibinqo (abrocitinib) is an oral small molecule that selectively inhibits Janus kinase 1.

Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin.

Atopic Dermatitis is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.

Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.

AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.

In Japan, AD affects approximately 3% of adults and 13% of children.