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
Click here to read full press release/ article | Ref: Businesswire | Image: Wall Street Journal
The post Pfizer’s Xeljanz (tofacitinib citrate) Receives EC’s Approval for the Treatment of Active Polyarticular JIA & Juvenile PsA first appeared on PharmaShots.
