Public health company The US Food and Drug Administration disclosed on Wednesday that Xeljanz's (tofacitinib) approval has been expanded to include adults with moderately to severely active ulcerative colitis, a chronic, inflammatory bowel disease affecting the colon.

The US FDA's approval of Xeljanz was awarded to Pfizer Labs.

According to the company, Xeljanz is the first oral medication approved for chronic use in this indication. Other FDA-approved treatments for the chronic treatment of moderately to severely active ulcerative colitis must be administered through an intravenous infusion or subcutaneous injection.

In conjunction, the efficacy of Xeljanz for the treatment of moderately to severely active ulcerative colitis was demonstrated in three controlled clinical trials.

This included two, eight week placebo-controlled trials that demonstrated that 10 mg of the company's Xeljanz twice daily induces remission in 17 to 18% of patients by week eight. Xeljanz at 5 mg or 10 mg dose given twice daily was effective in inducing remission by week 52 in 34% and 41% of patients, respectively.

Additionally, the safety of chronic use of Xeljanz for ulcerative colitis was studied in the 52-week placebo-controlled trial. Additional supportive safety information was collected from patients who received treatment in an open-label long-term study, concluded the company.