- The Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved Pfizer Inc’s (NYSE:PFE) Cibinqo (abrocitinib) for atopic dermatitis (AD).
- Related content: Benzinga’s Full FDA Calendar.
- The approval covers adults and adolescents aged 12 years and older AD patients with inadequate response to existing therapies.
- Abrocitinib is an oral, once-daily, Janus kinase 1 (JAK1) inhibitor.
- Cibinqo will be available in Japan in doses of 100mg and 200mg.
- Regulatory applications for abrocitinib have been submitted to countries worldwide for review, including the U.S., Australia, and the European Union.
- The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Cibinqo earlier this month.
- Also Read: FDA Hits JAK inhibitors With Heart Safety, Cancer Warnings: All You Need To Know.
- Price Action: PFE stock is down 0.07% at $43.50 during the premarket session on the last check Thursday.
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