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Review
. 2021 Dec;81(18):2149-2157.
doi: 10.1007/s40265-021-01638-3.

Abrocitinib: First Approval

Emma D Deeks  1 , Sean Duggan  2
Affiliations
Review

Abrocitinib: First Approval

Emma D Deeks et al. Drugs. 2021 Dec.

Erratum in

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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Conflict of interest statement

The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Emma Deeks is a contracted employee of Adis International Ltd/Springer Nature and Sean Duggan is a salaried employee of Adis International Ltd/Springer Nature, and declare no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

References

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    1. He H, Guttman-Yassky E. JAK inhibitors for atopic dermatitis: an update. Am J Clin Dermatol. 2019;20(2):181–192. doi: 10.1007/s40257-018-0413-2. - DOI - PubMed
    1. Agency MHPR. Abrocitinib (CIBINQO®): 50mg film-coated tablets: summary of product characteristics. 2021. https://mhraproducts4853.blob.core.windows.net/docs/3b68809595392199c87a.... Accessed 13 Sept 2021.
    1. Agency MHPR. Abrocitinib (CIBINQO®): 100mg film-coated tablets: summary of product characteristics. 2021. https://mhraproducts4853.blob.core.windows.net/docs/cec4db859df0798598d5.... Accessed 13 Sept 2021.
    1. Agency MHPR. Abrocitinib (CIBINQO®): 200mg film-coated tablets: summary of product characteristics. 2021. https://mhraproducts4853.blob.core.windows.net/docs/9106b0ca62531780c942.... Accessed 13 Sept 2021.

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