Pfizer issued the following announcement on September 30.
Pfizer Inc. (NYSE: PFE) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved CIBINQO® (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.
“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,” said Angela Hwang, Group President, Pfizer Biopharmaceuticals Group. “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 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 (MHRA) granted Great Britain marketing authorization for CIBINQO earlier this month.
Original source can be found here.
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