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# FDA Delays Decisions on Rinvoq Supplemental NDAs
- URL: https://www.fdaweb.com/fda-delays-decisions-on-rinvoq-supplemental-ndas/
- Published: 2021-06-25T12:00:00.000Z
- Updated: 2026-09-14T17:04:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149629

FDA has told AbbVie that it will not meet the user fee action dates for two supplemental NDAs for Rinvoq (upadacitinib), a JAK inhibitor for treating adults with active psoriatic arthritis and adults with active ankylosing spondylitis. The agency cited its ongoing review of Pfizer’s post-marketing study, ORAL Surveillance, that is evaluating Xeljanz (tofacitinib) in patients with rheumatoid arthritis, AbbVie says.

Ongoing FDA safety concerns with JAK inhibitors have caused review extensions for Eli Lilly/Incyte and Pfizer submissions. The drug class concerns arose from an FDA-required safety study when Pfizer’s Xeljanz (tofacitinib) was approved in 2012 for rheumatoid arthritis. In [2/2019](https://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr?ref=fdaweb.com) and [7/2019](https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and?ref=fdaweb.com), FDA warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice daily dosage, and as a result, approved a Boxed Warning*.*  

Rinvoq was approved in 2019 for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.