By Fineline Cube 
US-based pharma giant AbbVie (NYSE: ABBV) announced regulatory approval from the US Food and Drug Administration (FDA) authorizing the use of its Rinvoq (upadacitinib) in giant cell arteritis (GCA). This follows a similar approval in the European Union (EU) earlier this month.
Understanding Giant Cell Arteritis
Giant cell arteritis (GCA) is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. It generally affects patients older than 50 years, most commonly between the ages of 70 and 80 years.
FDA Approval Based on Clinical Trial Results
The FDA approval is based on positive results from the pivotal Phase III SELECT-GCA study. In the study, 46.4% of patients receiving Rinvoq 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.002), achieving the primary endpoint.-Fineline Info & Tech