Rinvoq is meant to treat adults with moderately to severely active Crohn's disease who have not had success with TNF (tumor necrosis factor) blockers. The daily pill is the first oral treatment for this group of patients.
Researchers evaluated its safety and effectiveness in two randomized trials in 857 patients with the disease. Participants received either 45 mg of Rinvoq or a placebo daily for 12 weeks.
More patients treated with the medication achieved remission than those treated with the placebo, the FDA said in a news release. Also, more people treated with the medication had improvement in intestinal inflammation, which was assessed with aThe FDA also assessed Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to the 12 weeks of medication. This group received 15 mg or 30 mg once daily or a placebo for a year.
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