AbbVie Receives Positive CHMP Opinion for Upadacitinib (RINVOQ®) for the Treatment of Adults with Giant Cell Arteritis

Core Viewpoint - AbbVie announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (RINVOQ®) for treating adult patients with giant cell arteritis (GCA), with a final decision expected in the first half of 2025 [1][2]. Group 1: Product Information - Upadacitinib (RINVOQ) is a selective and reversible JAK inhibitor being studied for various immune-mediated inflammatory diseases, including GCA [7]. - If approved, upadacitinib would be the first and only oral advanced therapy for adults with GCA [1]. - RINVOQ is already approved in the EU for several conditions, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis [2][8][12]. Group 2: Clinical Trial Data - The positive opinion is based on the pivotal Phase 3 SELECT-GCA clinical trial, which evaluated the efficacy and safety of upadacitinib in adults aged 50 and older with GCA [2][5]. - The trial involved 428 patients and demonstrated that the primary endpoint of sustained remission and key secondary endpoints were met [5][6]. - The safety profile of upadacitinib during the trial was consistent with that observed in other approved indications [2][5]. Group 3: Disease Background - GCA is an inflammatory disease that can lead to severe outcomes such as blindness and stroke if untreated [2][4]. - It is the most common vasculitis affecting adults in Western countries, with the highest risk among white women over 50 years old [4].