Tofacitinib Receives FDA Approval for Treatment of Ulcerative Colitis

Tofacitinib is indicated for the treatment of adult patients with severely active ulcerative colitis, severely active rheumatoid arthritis (RA), or psoriatic arthritis (PsA).

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.