FDA Expands Indication of Tofacitinib

The US Food and Drug Administration (FDA) has expanded the indication for Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis (UC), making it the first oral medication approved for chronic use in this indication.

The approval was granted following the success of 3 controlled clinical trials. In the first trial, 10-mg Xeljanz administered twice daily was shown to induce remission in 17% to 18% of patients by week 8.

In a second trial of patients with clinical response by week eight, twice-daily 5-mg and 10-mg Xeljanz effectively induced remission by week 52 in 34% and 41% of patients, respectively.

In a third trial of patients who achieved remission after 8 weeks of treatment, 35% and 47% achieved sustained corticosteroid-free remission with 5-mg and 10-mg Xeljanz, respectively.

The most commonly reported adverse events with Xeljanz for UC included diarrhea, elevated cholesterol levels, and headache, among others.

—Christina Vogt

Reference:

FDA approves new treatment for moderately to severely active ulcerative colitis [press release]. US Food and Drug Administration. May 30, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm609225.htm Accessed on May 30, 2018.