RINVOQ ® (upadacitinib) Receives FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
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 ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This FDA approval is the first indication for RINVOQ in gastroenterology and is supported by efficacy and safety data from three Phase 3 randomized, double-blind, placebo-controlled clinical studies.
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“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, chief scientific officer, 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.”
The two induction studies (U-ACHIEVE and U-ACCOMPLISH) utilized RINVOQ 45 mg once daily for 8 weeks, and then 15 mg or 30 mg once daily for the maintenance study (U-ACHIEVE maintenance) through 52 weeks. Across all clinical trials, significantly more patients treated with RINVOQ achieved clinical remission at weeks 8 and 52, the primary endpoint based on the mMS: stool frequency subscore (SFS) ≤ 1 and not greater than Baseline, rectal bleeding subscore (RBS) = 0, endoscopy subscore (ES) of ≤ 1 without friability, compared to placebo. In addition, the studies met all ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), as well as corticosteroid-free clinical remission in the maintenance study. All primary and ranked secondary endpoints achieved p-values of <0.001 versus placebo.
“Ulcerative colitis patients live with unpredictable symptoms such as increased stool frequency and bleeding, which can make daily activities difficult,” said Maria T. Abreu, M.D., Professor of Medicine, Professor of Microbiology and Immunology, University of Miami Miller School of Medicine and Director, 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.”