Pfizer has reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) authorized CIBINQO® (abrocitinib), a novel therapy for moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older who have had an inadequate response to existing treatments.
CIBINQO® already received marketing authorisation in the United Kingdom from the Medicines and Healthcare Products Regulatory Agency (MHRA) on September 09 this year. The once-daily oral drug acting as Janus kinase 1 (JAK1) inhibitor will be made available in Japan in doses of 100mg and 200mg.
Angela Hwang, Group President, Pfizer Biopharmaceuticals Group stated:
“There have been limited treatment options available for moderate to severe atopic dermatitis and we’re hopeful for the positive impact CIBINQO may have on the lives of people in Japan living with this chronic and potentially debilitating disease. We want to thank the Japanese Ministry of Health, Labour and Welfare, as well as all those who participated in our extensive clinical trial program and their families, for making this important treatment option a reality. Our priority will now be to ensure CIBINQO is routinely accessible to as many patients as possible.”
The encouraging outcomes of 1,513 patients across four Phase 3 trials spanning from 12 to 16 weeks of treatment, as well as a long-term extension study from a robust clinical trial program, led to the approval of CIBINQO in Japan.
Furthermore, regulatory applications for CIBINQO® (abrocitinib), have been failed for evaluation all over the world, including the United States, Australia and the European Union.
About CIBINQO® (abrocitinib)
CIBINQO® (abrocitinib) is an oral small molecule that selectively inhibits Janus kinase (JAK) 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 (TSLP).
About Atopic Dermatitis
AD is a chronic inflammatory skin disease characterized by erythema, itching, skin barrier defects such as the formation of lesions, papules, oozing and crusts.
AD is one of the most prevalent chronic relapsing childhood dermatoses, affecting 3% of adults and 13% of children in Japan and up to 10% of adults and 20% of children globally.