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FDA Approves Upadacitinib for GCA

  |  Issue: July 2025  |  

During the study, no safety differences were identified between patients who received upadacitinib or placebo. Additionally, no major adverse cardiovascular events occurred in study patients who received upadacitinib.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

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References

  1. Rinvoq (upadacitinib) receives U.S. FDA approval for giant cell arteritis [news release]. AbbVie Inc. 2025 Apr 29.
  2. Highlights of prescribing information: Rinvoq LQ (upadacitinib). U.S. Food & Drug Administration. 2025 Apr 28.
  3. New drug application approval: Rinvoq (upadacitinib) extended-release tablets. U.S. Food & Drug Administration. 2019 Aug 16.
  4. Blockmans D, Penn SK, Setty AR, et al. A phase 3 trial of upadacitinib for giant cell arteritis. N Engl J Med. 2025 May 29;392(20):2013–2024.

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