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Review
. 2020 Dec;80(18):1987-1997.
doi: 10.1007/s40265-020-01439-0.

Filgotinib: First Approval

Sohita Dhillon  1 , Susan J Keam  2
Affiliations
Review

Filgotinib: First Approval

Sohita Dhillon et al. Drugs. 2020 Dec.

Erratum in

Abstract

Filgotinib (Jyseleca®) is an oral, ATP-competitive, reversible JAK1 preferential inhibitor that is being developed by Galapagos NV and Gilead Sciences for the treatment of inflammatory autoimmune diseases, including inflammatory arthritis and inflammatory bowel disease. The JAK-STAT signalling pathway has been implicated in the pathogenesis of inflammatory and autoimmune diseases, and filgotinib modulates this pathway by preventing the phosphorylation and activation of STATs. In September 2020, filgotinib received its first approvals in the EU and Japan. In the EU, filgotinib is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs). In Japan, filgotinib is indicated for the treatment of RA in patients who had an inadequate response to conventional therapies (including prevention of structural damage to joints). Clinical studies of filgotinib for the treatment of inflammatory autoimmune diseases are ongoing worldwide. This article summarizes the milestones in the development of filgotinib leading to this first approval.

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Conflict of interest statement

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. Sohita Dhillon is a contracted employee of Adis International Ltd/Springer Nature and Susan J. Keam 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.

Figures

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Key milestones in the development of filgotinib. NDA New Drug Application, RA rheumatoid arthritis, UC ulcerative colitis
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Chemical structure of filgotinib
See this image and copyright information in PMC

References

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    1. O'Shea JJ, Schwartz DM, Villarino AV, et al. The JAK-STAT pathway: impact on human disease and therapeutic intervention. Annu Rev Med. 2015;66:311–328. doi: 10.1146/annurev-med-051113-024537. - DOI - PMC - PubMed
    1. European Medicines Agency. Filgotinib (Jyseleca®): summary of product characteristics. 2020. https://www.ema.europa.eu/. Accessed 30 Sep 2020.
    1. Durez P, Hoekema A, Huizinga T, et al. Treatment innovation for patients: a collaborative network in the Benelux and an inside view of 20 years of Galapagos. Acta Clin Belg. 2020 doi: 10.1080/17843286.2020.1812830. - DOI - PubMed
    1. Gilead Sciences. Jyseleca® (filgotinib) approved in Japan for rheumatoid arthritis [media release]. 25 Sep 2020. https://www.gilead.com.

MeSH terms