FDA approves Xeljanz for moderate-to-severe UC
The FDA has expanded the approval of Xeljanz to include use by adults with moderately to severely active ulcerative colitis.
Xeljanz (tofacitinib, Pfizer) is the first oral medication approved for chronic use to treat UC, the agency said in a press release.
“New treatments are needed for patients with moderately to severely active ulcerative colitis,” Julie Beitz, MD, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.”
The approval was backed by three controlled clinical trials, including two eight-week placebo control trials that showed 10 mg of Xeljanz taken twice daily induces remission in 17% to 18% of patients by week eight. In a placebo-controlled trial of patients who achieved remission by week eight, the results demonstrated that a 5 mg or 10 mg dose given twice daily effectively induced remission by week 52 in 34% and 41% of patients respectively, according to the FDA.
The FDA previously approved Xeljanz for the treatment of rheumatoid arthritis in 2012 and for the treatment of psoriatic arthritis in 2017.
Disclosures: Beitz is employed by the FDA.