AbbVie(ABBV) Prnewswire·2025-04-08 06:00Core Insights - AbbVie announced that the European Commission granted marketing authorization for RINVOQ® (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients, making it the first and only oral JAK inhibitor approved in the EU for this condition [1][4]. Group 1: Product Approval and Significance - The approval of RINVOQ provides a new treatment option for patients with GCA, a condition that primarily affects older adults and can lead to severe complications such as vision loss [2][4]. - RINVOQ's approval is based on the results from the Phase 3 SELECT-GCA trial, which demonstrated significant efficacy in achieving sustained remission and reducing steroid exposure compared to placebo [4][8]. Group 2: Clinical Trial Results - In the SELECT-GCA trial, 46.4% of patients receiving RINVOQ achieved sustained remission at week 52, compared to 29.0% in the placebo group (p=0.002) [5][8]. - Key secondary endpoints showed that 34.3% of patients on RINVOQ experienced at least one disease flare, compared to 55.6% in the placebo group (p=0.001), and cumulative steroid exposure was significantly lower in the RINVOQ group (median exposure of 1615 mg vs. 2882 mg, p<0.001) [5][6]. Group 3: Safety Profile - The safety profile of RINVOQ in the trial was consistent with other approved indications, with serious infections occurring in 5.7% of the RINVOQ group compared to 10.7% in the placebo group [3][40]. - No major adverse cardiac events were reported in the RINVOQ group, while two events occurred in the placebo group [6][40]. Group 4: Broader Context of RINVOQ - RINVOQ is already approved for multiple indications in the EU, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, marking the eighth approved indication for the drug [4][10]. - The drug is a selective and reversible JAK inhibitor, which is being studied for various immune-mediated inflammatory diseases [9][10].