FDA Approves Rinvoq for Ulcerative Colitis
This approval is the first indication for Rinvoq in gastroenterology.
The FDA has approved AbbVie’s Rinvoq (upadacitinib) for the treatment of adults with moderately to severely ulcerative colitis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. This approval is the first indication for Rinvoq in gastroenterology. It was approved in two dose strengths (15 mg and 30 mg).
“There remains an unmet need for patients with moderately to severely active UC, who suffer from debilitating symptoms that are often unpredictable and burdensome,” Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie, said in a press release.
The approval is based on data from three phase 3 studies. Across all trials, more patients treated with Rinvoq achieved clinical remission at weeks 8 and 52, the primary endpoint. In addition, the studies met all ranked secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement, as well as corticosteroid-free clinical remission in the maintenance study.
Rinvoq is a JAK inhibitor and is also approved to treat moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and moderate-to-severe atopic dermatitis.
An estimated 1.3% of U.S. adults (3 million) reported being diagnosed with inflammatory bowel disease (either Crohn’s disease or ulcerative colitis), according to the CDC. The annual incidence is 10 to 12 cases per 100,000 people, and the prevalence rate is 35 to 100 cases per 100,000 people. Ulcerative colitis affects the colon; Crohn’s can involve any component of the gastrointestinal tract. Symptoms of ulcerative colitis include rectal bleeding, pain, and frequent stools. It is slightly more common in men.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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