Shots:

• The approval is based on P-III study including 2 phases assessing tofacitinib (5mg or 1mg/mL oral solution- bid) for 44wks. The 2phases includes an 18 wks. open-label- run-in phase study of 225 patients and a 26wks. PBO controlled withdrawal study of 173 patients
• Results: the study met its 1EP showing ACR30 response at the end of the run-in phase; the occurrence of disease flare in patients (31% vs 55%) @44wks. The approval makes Xeljanz the first and only JAK inhibitor approved in the US for pcJIA
• The US FDA has approved the two formulations of Xeljanz (a tablet and an oral solution) and are dosed based on weight. The oral solution is expected to be available by the end of Q1’21 while the tablets (5mg) are available instantly

­ Ref: Pfizer | Image: CNC