By Fineline Cube 
US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval in the European Union for its oral JAK inhibitor Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA). This approval makes Rinvoq the first and only JAK inhibitor approved in the EU, as well as in Iceland, Liechtenstein, and Norway, for this condition.
Disease Background
Giant cell arteritis (GCA) is an autoimmune disease characterized by inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. It primarily affects individuals over the age of 50, with the highest incidence observed between the ages of 70 and 80.
Clinical Trial Results
The approval is supported by results from the pivotal Phase III SELECT-GCA study. In this trial, 46.4% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared to 29.0% of patients receiving placebo with a 52-week steroid taper regimen (p=0.002). The study also met key secondary endpoints, demonstrating Rinvoq’s ability to reduce disease flares, lower cumulative steroid exposure, and maintain sustained complete remission.-Fineline Info & Tech