4 June 2018 - - Silver Spring, Maryland-based public health protection provider US Food and Drug Administration (FDA) has expanded the approval of Xeljanz (tofacitinib) to include adults with moderately to severely active ulcerative colitis, the agency said.
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.
Ulcerative colitis is a chronic, inflammatory bowel disease affecting the colon. Patients experience recurrent flares of abdominal pain and bloody diarrhea. Other symptoms include fatigue, weight loss and fever.
More than 900,000 patients are affected in the US, many of them experiencing moderately to severely active ulcerative colitis, and there is currently no cure.
The efficacy of Xeljanz for the treatment of moderately to severely active ulcerative colitis was demonstrated in three controlled clinical trials. This included two 8-week placebo-controlled trials and a 52-week placebo-controlled trial that concurrently evaluated the safety of chronic use of Xeljanz for ulcerative colitis.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.