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# AbbVie Gains Rinvoq Psoriatic Arthritis Approval
- URL: https://www.fdaweb.com/abbvie-gains-rinvoq-psoriatic-arthritis-approval/
- Published: 2021-12-15T12:00:00.000Z
- Updated: 2026-09-14T17:25:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150780

FDA has approved AbbVie’s JAK inhibitor Rinvoq (upadacitinib; 15 mg, once daily) for treating adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. Approval is based on data from two pivotal Phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 which demonstrated Rinvoq achieving greater responses compared with a placebo (71% and 57%, respectively), according to the company. Previously, Rinvoq was approved as a treatment for rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

The supplemental NDA review action had been delayed by an FDA safety review ([see earlier story](https://www.fdaweb.com/fda-delays-decisions-on-rinvoq-supplemental-ndas/)) of all JAK inhibitors. 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*. In September,* FDA [ordered](https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death?utm%5Fmedium=email&utm%5Fsource=govdelivery) a drug class warning after reviewing a recent clinical trial that showed an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with Pfizer’s arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib).