FDA Approves First Pill to Treat Moderate-to-Severe Crohn Disease
Medically reviewed by Drugs.com.
By Physician’s Briefing Staff HealthDay Reporter
FRIDAY, May 19, 2023 -- Patients with Crohn disease have a new treatment option, following U.S. Food and Drug Administration approval of Rinvoq (upadacitinib).
Rinvoq is meant to treat adults with moderately to severely active Crohn disease who have not had success with tumor necrosis factor blockers. The daily pill is the first oral treatment for this group of patients.
The medication was previously approved for several other conditions, including eczema, rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, according to the website of pharmaceutical company AbbVie.
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 a colonoscopy.
The FDA also assessed Rinvoq as a maintenance treatment, evaluating 343 patients who had responded to the 12 weeks of medication. This group received 15 or 30 mg once daily or a placebo for a year. More of those on the maintenance treatment achieved remission and reduced intestinal inflammation than those on the placebo. Side effects of the medication were upper respiratory tract infections, anemia, fever, acne, herpes zoster, and headache.
The drug is not recommended for use with other Janus kinase inhibitors, biological therapies for Crohn disease, or strong immunosuppressants, including azathioprine and cyclosporine. Among the risks are serious infections, death, cancer, major adverse cardiovascular events, and thrombosis.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted May 2023
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
