Expanded Approval for Pfizer’s Xeljanz

FDA has expanded the approval of Pfizer’s Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis, the first oral drug approved for chronic use in this indication. Other treatments must be administered through an intravenous infusion or subcutaneous injection, according to an agency release.

Expanded approval is based on data from three controlled clinical trials. This included two eight-week placebo-controlled trials that demonstrated that 10 mg of Xeljanz given twice daily induces remission in about 18% of patients. “In a placebo-controlled trial among patients who achieved a clinical response by week eight, Xeljanz, at a 5 mg or 10 mg dose given twice daily, was effective in inducing remission by week 52 in 34% and 41% of patients, respectively,” FDA says.

Xeljanz was originally approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.