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 has also received a positive opinion in the EU and is under regulatory review in the UK and China. This article summarizes the milestones in the development of ritlecitinib leading to this first approval for severe alopecia areata.
Supplementary InformationThe online version contains supplementary material ailable at 10.1007/s40265-023-01928-y.
Digital Features for this AdisInsight Report can be found at 10.6084/m9.figshare.23706567. Open in a new tabRitlecitinib (LITFULO™): Key Points A kinase inhibitor being developed by Pfizer for the treatment of alopecia areata, vitiligo, ulcerative colitis and Crohn’s disease Received its first approval on 23 June 2023 in the USA Approved for the treatment of severe alopecia areata in adults and adolescents 12 years and older Open in a new tabIntroductionRitlecitinib (LITFULO™) is a kinase inhibitor that is being developed by Pfizer for the treatment of alopecia areata, vitiligo, ulcerative colitis and Crohn’s disease. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family [1].
On 23 June 2023, ritlecitinib received its first approval in the USA for the treatment of severe alopecia areata in adults and adolescents 12 years and older [1, 2]. Alopecia areata is an autoimmune disease characterized by loss of scalp, face and/or body hair [2]. Ritlecitinib is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, ciclosporin or other potent immunosuppressants [1]. The recommended dosage of ritlecitinib is 50 mg orally once daily, with or without food. Treatment should be interrupted if the absolute lymphocyte count (ALC) is