USFDA approves AbbVie giant cell arteritis drug Rinvoq in adults
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-04-30 11:00 GMT | Update On 2025-04-30 11:00 GMT
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North Chicago, Ill.: AbbVie has received approval from the U.S. Food and Drug Administration (FDA) for RINVOQ (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).
This comes after the European Commission recently granted marketing authorization of RINVOQ for the treatment of GCA in adult patients.
The approvals are supported by results of the pivotal Phase 3 SELECT-GCA clinical trial, which met the primary endpoint of sustained remission (46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission from week 12 to week 52, compared to 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen; p=0.002).
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