Tofacitinib Receives FDA Approval for Treatment of Ulcerative Colitis

The FDA has approved tofacitinib (Xeljaz XR, Pfizer, Inc) 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 of Inflammation & Immunology for Pfizer Global Product Development. “We are pleased to now offer patients with moderately to severely active ulcerative colitis and their health care providers a convenient once-daily dosing option with [tofactitinib].”

Tofacitinib is indicated for the treatment of adult patients with the following 3 indications:

• Moderately to severely active UC for patients who have had an inadequate response to or who are intolerant to TNF blockers.
• Moderately to severely active RA who have had an inadequate response or intolerance to methotrexate.
• Active PsA, for patients who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs.

Tofacitinib 10 mg twice daily or tofacitinib 22 mg once daily may be given for 8 weeks or up to a maximum of 16 weeks as induction therapy. Following tofacitinib 5 mg twice daily, tofacitinib 11 mg once daily may be given as maintenance treatment.

Reference

FDA Approves XELJANZ XR (Tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis [press release]. Pfizer website. Published December 12, 2019. https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_xeljanz_xr_tofacitinib_extended_release_tablets_for_the_treatment_of_ulcerative_colitis. Accessed December 13, 2019.