FDA Approves Extended-Release Tofacitinib for Ulcerative Colitis

The US Food and Drug Administration (FDA) has approved tofacitinib extended-release 11 mg and 22 mg tablets (XELJANZ XR) for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis.

The indication, granted to Pfizer, is designated for patients who have an inadequate response or intolerance to TNF blockers. It is not recommended to be used in combination with biological therapies for ulcerative colitis, or with potent immunosuppressants.

The Janus kinase (JAK) inhibitor was previously approved in the US for treating moderately to severely active rheumatoid arthritis post-methotrexate failure and active psoriatic arthritis post-DMARD failure. It has been observed in 50-plus worldwide clinical trials—20 of which had involved patients with rheumatoid arthritis—and has been prescribed to 200,000-plus adult patients in the last 7 years.

Its indication was originally expanded to benefit patients with ulcerative colitis in May 2018, when clinical trial data showed remission in nearly 20% of patients with ulcerative colitis who were treated with 10 mg therapy over 8 weeks.

Michael Corbo, chief development officer of Inflammation & Immunology at Pfizer Global Product Development, expressed pleasure in being able to offer a once-daily dosing option of tofacitinib for ulcerative colitis.

“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,” Corbo said in a statement.