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22-11-2021 | JAK inhibitors | Adis Journal Club | Article

Drugs

Abrocitinib: First Approval

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Authors: Emma D. Deeks & Sean Duggan

Abstract

Abrocitinib (Cibinqo®) is an oral small-molecule inhibitor of Janus kinase 1 (JAK1) being developed by Pfizer for the treatment of moderate-to-severe atopic dermatitis (AD). In September 2021, abrocitinib was approved in the UK and Japan for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy. Abrocitinib has also received a positive CHMP opinion in the EU for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Regulatory applications for the drug have also been submitted for review to several other countries, including the USA and Australia. This article summarizes the milestones in the development of abrocitinib leading to this first approval for the treatment of moderate-to-severe AD.

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Abrocitinib (Cibinqo®): Key Points

Oral, small-molecule inhibitor of JAK1 being developed by Pfizer for the treatment of moderate-to-severe AD.

Received its first approval on 9 September 2021 in the UK.

Approved for the treatment of moderate-to-severe AD in adults and adolescents 12 years and older who are candidates for systemic therapy.

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