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FDA Panel Backs Pfizer's Xeljanz For Ulcerative Colitis

Pfizer Inc. (PFE) Thursday announced a favorable outcome of U.S. Food and Drug Administration Gastrointestinal Drugs Advisory Committee meeting on Pfizer's supplemental New Drug Application for Xeljanz (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis.

"Today's discussion underscored the significant unmet need that exists for people living with ulcerative colitis, a disease that is often debilitating and difficult to control. We are encouraged about the positive outcome of today's GIDAC meeting," said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

"If approved, tofacitinib will be the first Janus kinase inhibitor and the first oral therapy for adults living with moderately to severely active ulcerative colitis. We look forward to working with the FDA as it completes the review of our pending application."

The role of the GIDAC is to provide recommendations to the FDA; however, the recommendations are not binding. FDA's decision on whether or not to approve tofacitinib for UC is expected by the Prescription Drug User Fee Act date in June 2018.

Ulcerative Colitis is a chronic and often debilitating inflammatory bowel disease that affects millions of people worldwide. Symptoms include chronic diarrhea with blood and mucus, abdominal pain and cramping, and weight loss.

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