RINVOQ Receives FDA Approval for Treatment of Adults With Moderately to Severely Active Ulcerative Colitis
The FDA has approved RINVOQ as a treatment for adults with moderate to severe active ulcerative colitis who have not had an adequate response to existing treatments.
AbbVie announced on March 16, 2022 that its treatment for moderate to severe active ulcerative colitis RINVOQ (upadacitinib) has received FDA approval. The treatment is for adults who have had an inadequate response or intolerance to tumor necrosis factor (TNF) blockers.
Ulcerative colitis (UC) is a chronic, idiopathic, immune-mediated inflammatory bowel disease that causes inflammation of the mucous membranes. Common symptoms and signs of ulcerative colitis include rectal bleeding, abdominal pain, bloody diarrhea, and fecal incontinence. The disease is unpredictable and variable among patients.
“There remains an unmet need for patients with moderately to severely active UC, who suffer from often unpredictable and distressing debilitating symptoms,” said Thomas Hudson, MD, senior vice president of research and development and chief scientific officer of ‘AbbVie. “With the approval of RINVOQ as a new treatment option, AbbVie continues its leadership in advancing research that can impact the lives of people with ulcerative colitis.”
“Patients with ulcerative colitis live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” said Maria T. Abreu, MD, professor of medicine and professor of microbiology. and Immunology at the University of Miami Miller School of Medicine and Director of the Crohn’s & Colitis Center, University of Miami Health System. “In clinical trials, RINVOQ has shown the ability to rapidly control symptoms in just eight weeks for many patients and sustained responses at one year. I believe these types of improvements can make a positive difference for my patients.”