28 September 2020 - Pfizer announced today that the U.S. FDA approved Xeljanz (tofacitinib) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis.
Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes Xeljanz the first and only Janus kinase inhibitor approved in the U.S. for the treatment of patients with polyarticular course juvenile idiopathic arthritis.
This approval was based on data from a Phase 3 trial including two phases: an 18-week open-label, run-in phase (including 225 patients), followed by a 26-week double-blind, placebo-controlled, randomised, withdrawal phase (including 173 patients) for a total duration of 44 weeks.