FDA Approves Xeljanz XR for Ulcerative Colitis

Pfizer’s Xeljanz XR (tofacitinib) extended release 11mg and 22mg tablets earned FDA approval for treatment of moderate to severe ulcerative colitis in adults after an inadequate response or intolerance to TNF blockers.

Xeljanz currently has three approved indications in the U.S.: moderate to severe active rheumatoid arthritis after methotrexate failure; active psoriatic arthritis after disease modifying antirheumatic drug failure; and moderately to severely active ulcerative colitis after tumor necrosis factor inhibitor failure.

Xeljanz earned almost $1.8 billion in global revenues for Pfizer in fiscal 2018, including $1.39 billion in the U.S.