www.fdanews.com/articles/199302-pfizers-xeljanz-approved-for-active-polyarticular-course-juvenile-idiopathic-arthritis
Pfizer’s Xeljanz Approved For Active Polyarticular-Course Juvenile Idiopathic Arthritis
September 30, 2020
The FDA has approved Pfizer’s Xeljanz (tofacitinib) in tablet and an oral solution for the treatment of children and adolescents with active polyarticular-course juvenile idiopathic arthritis (pcJIA).
The approval was based on positive results from a phase 3 clinical trial which found that the occurrence of disease flare-ups in patients treated with Xeljanz was lower than those given a placebo.
Pfizer anticipates that the oral solution will be available in the first quarter of next year. The 5 mg tablets are already available.