The U.S. Food and Drug Administration today expanded the approval of tofacitinib to include adults with moderately to severely active ulcerative colitis. tofacitinib 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.
“New treatments are needed for patients with moderately to severely active ulcerative colitis,” said M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an alternative therapy for a debilitating disease with limited treatment options.” Ulcerative colitis is a chronic, inflammatory bowel disease affecting the colon. Patients experience recurrent flares of abdominal pain and bloody diarrhoea.…
