FDA Approves AbbVie’s JAK Inhibitor Therapy to Treat GCA
Supported by clinical trial data, this new indication for upadacitinib provides GCA sufferers with an alternative treatment option that can achieve sustained remission.
The U.S. FDA has granted approval to AbbVie for its Janus Kinase (JAK) inhibitor therapy (upadacitinib, RINVOQ) as a treatment for adults with giant cell arteritis (GCA). The regulatory decision was announced by AbbVie in an April 29, 2025 press release (1).
Also known as temporal arteritis, GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other arteries that are medium or large in size. The disease can result in potentially severe outcomes, such as blindness, aortic aneurysm, or stroke, and is more likely to develop in Caucasian women over the age of 50 years.
Upadacitinib is a JAK inhibitor that is under investigation for several immune-mediated inflammatory diseases. The approval for its use as a treatment for adults with GCA was supported by data from the Phase III SELECT-GCA clinical trial, which investigated the safety and efficacy of the therapy in combination with a tapered steroid regimen compared with a placebo-based combination treatment. The trial, which evaluated 428 patients with GCA, found that 46.4% of patients treated with 15 mg of upadacitinib in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared with only 29% of patients treated with the placebo combination regimen.
“This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission,” said Roopal Thakkar, M.D., Executive Vice President, Research and Development, Chief Scientific Officer, AbbVie, in the press release (1). “With this new indication for RINVOQ, we are underscoring AbbVie's commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases.”
“Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease,” added Peter A. Merkel, M.D., MPH, Chief of Rheumatology at the University of Pennsylvania, Philadelphia, and SELECT-GCA Trial Investigator, in the press release (1). “We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission.”
The FDA’s decision follows an approval from the European Commission (E.C.) for the therapy as a treatment for adults with GCA earlier in April 2025 (2). As with the U.S. approval, the European approval was also supported by data from the Phase III SELECT-GCA clinical trial.
“The E.C. approval of RINVOQ in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA — a particularly vulnerable population due to older age and frequent comorbidities,” remarked Thakkar in a company press release about the European approval (2). “This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission.”
References
AbbVie. RINVOQ (Upadacitinib) Receives U.S FDA Approval for Giant Cell Arteritis (GCA). Press Release, April 29, 2025.
AbbVie. AbbVie Announces European Commission Approval of RINVOQ (Upadacitinib) for the Treatment of Adults with Giant Cell Arteritis. Press Release, April 8, 2025.