Pfizer gets FDA nod for Xeljanz XR
Pfizer has received the Food and Drug Administration’s blessing for Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis, or UC, after an inadequate response or intolerance to TNF blockers.
Xeljanz (tofacitinib) is approved for adult patients in three indications: moderately to severely 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.
"Ulcerative colitis is a chronic inflammatory disease of the colon that can significantly affect a patient’s quality of life and be emotionally burdensome due to symptoms, flares and complications,” said Michael Corbo, chief development officer, inflammation and immunology, Pfizer global product development. “We are pleased to now offer patients with moderately to severely active ulcerative colitis and their healthcare providers a convenient once-daily dosing option with Xeljanz.”