FDA approves Upadacitinib for Crohn's disease in adults
The U.S. Food and Drug Administration (FDA) has approved Upadacitinib for treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers.
This is the seventh FDA approval for RINVOQ across rheumatology, dermatology, and gastroenterology, where it is now indicated in both ulcerative colitis and Crohn's disease.
"AbbVie recognizes the need for more treatment options for Crohn's disease that can help address both rapid relief of symptoms along with the visible reduction of intestinal lining damage," said Thomas Hudson, M.D., senior vice president of research and development, chief scientific officer, AbbVie. "We're pleased that RINVOQ may provide this relief and is now available to treat Crohn's disease."
Endoscopic Response and Clinical RemissionThe approval is supported by data from two induction studies, U-EXCEED and U-EXCEL, and the U-ENDURE maintenance study.1 Statistical significance was achieved for the co-primary endpoints and key secondary endpoints with RINVOQ 45 mg in the induction studies and RINVOQ 15 mg and 30 mg in the maintenance study compared to placebo.
RINVOQ Safety Considerations
- Overall, the safety profile observed in patients with Crohn's disease treated with RINVOQ was consistent with the known safety profile for RINVOQ in other indications.
- RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower ability to fight infections. Serious infections, some fatal, occurred, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses.
- Increased risk of death in people age 50+ with at least 1 heart disease risk factor.
- Cancer and immune system problems. Increased risk of some cancers, including lymphoma and skin. Current or past smokers have higher risk for lymphoma and lung cancer.
- Increased risk of major cardiovascular events such as heart attack, stroke, or death in people 50+ with at least 1 heart disease risk factor, especially in current or past smokers.
- Blood clots, some fatal, in veins of the legs or lungs and arteries. This occurred more often in people 50+ with at least 1 heart disease risk factor.
- Serious allergic reactions. Do not take if allergic to RINVOQ or its ingredients.
- Tears in the stomach or intestines; changes in certain laboratory test results.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.