RINVOQ Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis

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FDA has approved RINVOQ as a treatment for adults with moderately to severely active ulcerative colitis who have not had an adequate response to existing treatments.

AbbVie announced on March 16, 2022 that its treatment for moderately to severely active ulcerative colitis RINVOQ (upadacitinib) has been granted approval by FDA. The treatment if meant 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 mucosal inflammation. 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 debilitating symptoms that are often unpredictable and burdensome," 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 our leadership in advancing research that can help impact the lives of people living with ulcerative colitis."


"Ulcerative colitis patients 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 Crohn's & Colitis Center, University of Miami Health System. "In clinical trials, RINVOQ showed its 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."

Source: AbbVie