AbbVie's Rinvoq Gets EU Nod for 8th Indication Giant Cell Arteritis

Core Viewpoint - AbbVie has received marketing approval from the European Commission for its drug Rinvoq to treat giant cell arteritis (GCA), marking the eighth approved indication for this medication [1][4]. Group 1: Rinvoq Approval and Clinical Data - Rinvoq (15 mg, once daily) is the first JAK inhibitor approved in the EU for GCA and the first oral advanced therapy for this condition [2]. - The approval was based on the phase III SELECT-GCA study, which demonstrated that 46% of GCA patients treated with Rinvoq achieved sustained remission compared to 29% in the placebo group [3]. Group 2: Financial Performance and Market Impact - Rinvoq generated sales of nearly $6 billion in 2024, reflecting a year-over-year increase of 50.4% due to ongoing label expansions [6]. - Combined sales of Rinvoq and AbbVie's other drug Skyrizi reached $17.7 billion in 2024, with expectations to exceed $31 billion by 2027 driven by market growth and new indications [8][9]. Group 3: Competitive Landscape - Rinvoq and Skyrizi have shown strong performance against other novel therapies in clinical studies, providing a competitive advantage in the market [8]. - Other JAK inhibitors, such as Pfizer's Xeljanz and Lilly/Incyte's Olumiant, are also present in the market, with Olumiant generating sales of $957.4 million and Xeljanz $1.17 billion in 2024 [10][11].