US Edition
FDA Tweaks JAK Inhibitor Indication in Inflammatory Bowel Disease
The FDA approved upadacitinib for adults with moderate to severe inflammatory bowel disease after one systemic therapy if tumor necrosis factor blockers are unsuitable.
- Recently, the U.S. Food and Drug Administration approved a supplemental new drug application updating upadacitinib's indication for adults with moderately to severely active ulcerative colitis and Crohn's disease.
- Phase 3 results showed U-ACHIEVE and U-ACCOMPLISH trials found 45 mg once per day for an 8-week induction period produced clinical remission rates approx 26% and 33% versus placebo 5% and 4%.
- Laboratory studies showed upadacitinib inhibited STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2, and investigators observed remission measured by the Crohn's Disease Activity Index .
- The label update allows healthcare providers to prescribe RINVOQ after one systemic therapy if TNF blockers are clinically inadvisable, and AbbVie's Patient Support Program and co-pay card may reduce costs to $0 per month for eligible commercially insured patients.
- Safety materials emphasize that RINVOQ can lower the ability to fight serious infections, including tuberculosis, and increase risks of blood clots and cardiovascular events in people 50+ with heart disease risk factors, especially in current or past smokers.
26 Articles
26 Articles
FDA Tweaks JAK Inhibitor Indication in Inflammatory Bowel Disease
(MedPage Today) -- The FDA updated the indication of the JAK inhibitor upadacitinib (Rinvoq) in inflammatory bowel disease (IBD) to account for cases where a patient may not be appropriate for a TNF blocker, drugmaker AbbVie announced on Monday...
Abbvie gets USFDA approval for updated indication statement for Rinvoq for Inflammatory Bowel Disease
North Chicago: AbbVie has received the U.S. Food and Drug Administration (FDA) approval for a supplemental new drug application (sNDA) that updates the indication statement for RINVOQ (upadacitinib)...
Farm Talk Newspaper
U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease
Updated indication allows the use of RINVOQ® (upadacitinib) prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic…
U.S. Food and Drug Administration (FDA) Approves Updated Indication Statement for RINVOQ® (upadacitinib) for the Treatment of Inflammatory Bowel Disease (2025-10-13)
-AbbVie today announced the U.S. Food and Drug Administration approval of a supplemental new drug application that updates the indication statement for RINVOQ ® for the treatment of adults with moderately to severely active ulcerative colitis and moderately to severely active Crohn's disease. Previously, RINVOQ was indicated for adults with moderately...
FDA Grants Rinvoq Updated Indication in IBD
The updated indication for the JAK inhibitor allows use in patients with moderately to severely active ulcerative colitis and Crohn’s disease after one systemic therapy if TNF blockers are inadvisable. Medscape Medical News Source link : https://www.medscape.com/viewarticle/fda-grants-rinvoq-updated-indication-ibd-2025a1000rph?src=rss Author : Publish date : 2025-10-14 16:08:00 Copyright for syndicated content belongs to the linked Source. The p…
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