FDA Approves XELJANZ XR (Tofacitinib) Tablets For Ulcerative Colitis

Pfizer Inc.announced today that the U.S. Food and Drug Administration (FDA) has approved 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 (UC), after an inadequate response or intolerance to TNF blockers.

“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 & 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.”

XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active UC, who have had an inadequate response or who are intolerant to TNF blockers. Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily may be given for eight weeks or up to a maximum of 16 weeks as induction therapy. Following, XELJANZ 5 mg twice daily or XELJANZ XR 11 mg once daily may be given as maintenance treatment. For patients with loss of response during maintenance treatment, XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily may be considered and limited to the shortest duration, with careful consideration of benefits and risks to the individual patient. Use the lowest effective dose needed to maintain response. Dosage adjustment is needed in patients with moderate and severe renal impairment or moderate hepatic impairment. For dosing adjustments, refer to the XELJANZ/XELJANZ XR Full Prescribing Information at: https://labeling.pfizer.com/ShowLabeling.aspx?id=959.-Business Wire