, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.
The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of(Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.
The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind.