FDA Approves Rinvoq for Ulcerative Colitis

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.