Pfizer’s Xeljanz Approved in EU for Adults with Moderate to Severe Ulcerative Colitis

Pfizer’s Xeljanz Approved in EU for Adults with Moderate to Severe Ulcerative Colitis
The European Commission has approved Pfizer's Xeljanz (tofacitinib) for the treatment of adults with moderate to severe active ulcerative colitis (UC) who have failed to fully respond to other therapies. The approved regimen is 10 mg of oral Xeljanz twice a day for at least eight weeks, after which patients can continue on the twice-daily therapy, either at 5 mg or 10 mg. Approval in the EU follows that of the U.S. Food and Drug Administration for the same indication. The European Medicines Agency’s Committee for Human Medicinal Products, responsible for assessing the quality, safety, and efficacy of investigational therapies, said that Xeljanz had a clear benefit over other therapies for UC treatment. “Ulcerative colitis is a chronic disease that can develop at any age, be difficult to manage and affect multiple aspects of daily life,” Angela Lukin, Pfizer's regional president of inflammation and immunology, said in a press release. “The EC approval of Xeljanz provides an additional treatment option that can help improve the care of adults in Europe living with this debilitating inflammatory bowel disease.” Xeljanz is a Janus kinase (JAK) inhibitor, which was first approved as a treatment for moderate to severe rheumatoid arthritis and adults with active psoriatic arthritis. The EC's decision was based on positive results from the Phase 3 OCTAVE trials — a global clinical program that included three studies, OCTAVE Induction 1 (NCT01458574), OCTAVE Induction 2 (NCT01465763), and OCTAVE Sustain (NCT01458951). Adults with moderately to severely active UC recruited to the OCTAVE Induction 1 and OCTAVE Induction 2 trials were randomized to a placebo or 10 mg of oral Xeljanz twice daily. Results from OCTAVE Induction 1 showed th
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