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Ritlecitinib: First Approval

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posted on 2023-08-06, 22:27 authored by Hannah A. Blair

Declarations

Funding 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. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.


Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.


Additional information about this Adis Drug Review can be found here


Abstract

Ritlecitinib (LITFULO™), an orally administered kinase inhibitor, is being developed by Pfizer for the treatment of alopecia areata, vitiligo, ulcerative colitis and Crohn’s disease. On 23 June 2023, ritlecitinib received approval in the USA for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Ritlecitinib was approved in Japan on 26 June 2023 for the treatment of alopecia areata (limited to intractable cases involving widespread hair loss). Ritlecitinib is under regulatory review for alopecia areata in the EU, the UK and China. This article summarizes the milestones in the development of ritlecitinib leading to this first approval for severe alopecia areata.


  

© Springer Nature Switzerland AG 2023


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