Abbvie: FDA Approves RINVOQ, 15 Mg, Once Daily, For Treatment Of Adults With Giant Cell Arteritis

–      RINVOQ (upadacitinib) is now the first and only oral Janus Kinase (JAK) inhibitor approved for the treatment of GCA in adults

–      Also known as temporal arteritis, GCA is the most common vasculitis affecting adults in Western countries2

–      This marks the ninth approved indication for RINVOQ in the U.S., across rheumatology, gastroenterology, and dermatology1

NORTH CHICAGO, Ill., April 29, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib), 15 mg, once daily, for the treatment of adults with giant cell arteritis (GCA).1 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).1

During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications.