Tofacitinib plus MTX was shown to be non-inferiority vs. adalimumab plus MTX, however, Xeljanz monotherapy did not meet its primary endpoint for non-inferiority vs.adalimumab plus MTX, or vs. Xeljanz plus MTX.
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The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.
The new PsA approval was based on data from the Phase 3 OPAL Broaden, OPAL Beyond, and OPAL Balance studies.
An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.