Pfizer’s Xeljanz (tofacitinib) won approval from the U.S. Food and Drug Administration (FDA)as a treatment for patients with moderately to severely active ulcerative colitis (UC), after an inadequate response or intolerance to tumor necrosis factor inhibitor (TNFi) blockers.
The FDA approved extended-release 11 mg and 22 mg tablets as a once-daily treatment from the chronic inflammatory condition. A 10 mg twice-per-day dose of Xeljanz was approved for moderately to severely active ulcerative colitis last year.
Ulcerative colitis is an inflammatory bowel disease that causes long-lasting inflammation and ulcers in the digestive tract. Symptoms typically develop over time but the discomfort can be debilitating and can sometimes lead to life-threatening complications, according to the Mayo Clinic. Some medications can reduce the signs and symptoms of the disease and bring about remission, but there is no cure. Ulcerative colitis affects approximately 907,000 people in the United States.
Michael Corbo, chief development officer of inflammation and immunology at Pfizer Global Product Development, said the symptoms, flares and complications of ulcerative colitis can “affect a patient’s quality of life and be emotionally burdensome.” Xeljanz can now be used to remedy those effects of the disease, Corbo said in a statement.
Pfizer noted in its announcement that 10 mg of Xeljanz twice per day and 22mg once per day is the recommended dose for a treatment period of eight to 16 weeks. That period of time can then be followed with twice per day 5mg doses of Xeljanz or 11 mg once per day. The medication is not recommended in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine, Pfizer added.
The latest approval for Xeljanz marks the third in the United States. The medication has also been approved for patients with moderately to severely active rheumatoid arthritis after methotrexate failure, active psoriatic arthritis after disease-modifying antirheumatic drug failure.
The approval of Xeljanz comes after concerns were raised earlier this year regarding high doses of the medication. In February, Pfizer announced it was shifting patients who had been taking 10 mg doses of the medication twice daily to a lower 5 mg dose twice per day in a post-marketing study required by the U.S. Food and Drug Administration. The monitoring board said that patients who received the 10 mg dose “had a statistically and clinically important difference in the occurrence of pulmonary embolism, compared with patients in this study who were treated with a TNFi.”
Following that, in July, the FDA approved new warnings about an increased risk of blood clots and of death in ulcerative colitis patients taking the 10 mg dose. The 10 mg twice daily dose of tofacitinib is only approved for the initial treatment of ulcerative colitis and for long-term use in limited situations. While the increased risks of blood clots and death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis, the FDA said.
