Shots:

• The approval is based on a P-III study which includes 2 phases i.e.- run-in & withdrawal phase evaluating efficacy & safety of tofacitinib (5mg tablet or mg/mL oral solution- BID) in 398 patients aged ≥2yrs. with polyarticular JIA & juvenile PsA who have had an inadequate response to previous therapy with DMARDs for 44wks.
• The study met its 1EPs i.e- patients achieved an ACR30 response at the end of the run-in phase; occurrence of disease flare (31% vs 55%) @44wks. & efficacy in juvenile PsA subtype population was consistent with polyarticular JIA
• Xeljanz (11mg- qd) has also received EC’s approval for active PsA who have had an inadequate response/intolerance to methotrexate or other DMARDs

Ref: Businesswire | Image: Wall Street Journal