U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults
NORTH CHICAGO, Ill., May 18, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib) for the treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.1 This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.1
- "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."
- Overall, the safety profile observed in patients with Crohn's disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.
- Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
- For those with limited or no health insurance, AbbVie offers myAbbVie Assist, a patient assistance program that provides RINVOQ at no charge to those who qualify.