-Â Â Â Â Updated indication allows the use of RINVOQ (upadacitinib) prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy , /PRNewswire/ --Â AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) that updates the indication statement for RINVOQ® (upadacitinib) for the treatment of adults w ...

Core Insights - AbbVie's RINVOQ (upadacitinib) has received FDA approval for the treatment of giant cell arteritis, marking it as the first oral JAK inhibitor approved for this condition in Western countries, and the ninth indication for the drug [1][6] Group 1: Market Dynamics - The approval of RINVOQ has intensified competition among pharmaceutical companies in the giant cell arteritis market [1] - DelveInsight estimates the giant cell arteritis market size to grow from USD 960 million in 2023 at a significant CAGR by 2034, driven by factors such as an increasing geriatric population and rising prevalence of cardiovascular disorders [14] Group 2: Treatment Landscape - The primary treatment for giant cell arteritis has traditionally involved high doses of corticosteroids like prednisone, with the aim of preventing serious complications such as blindness [3] - ACTEMRA/ROACTEMRA (tocilizumab) was the first approved treatment for giant cell arteritis in Europe, with its approval supported by the Phase III GiACTA study demonstrating improved remission rates [4][7] - RINVOQ's pivotal Phase 3 SELECT-GCA trial showed that 46.4% of patients achieved sustained remission with RINVOQ compared to 29.0% on placebo [7] Group 3: Emerging Therapies - Companies like Novartis and CSL/Kiniksa Pharmaceuticals are conducting clinical trials for new treatment options, indicating a need for more effective therapies in the giant cell arteritis space [10][12] - The anticipated launch of emerging therapies is expected to transform the market landscape, offering new standards of care and opportunities for innovation [13]

Core Insights - AbbVie has received FDA approval for RINVOQ (upadacitinib) as the first oral JAK inhibitor for treating giant cell arteritis (GCA) in adults, marking its ninth approved indication in the U.S. [1][2] - The approval is based on the successful results of the Phase 3 SELECT-GCA clinical trial, which demonstrated that 46.4% of patients on RINVOQ achieved sustained remission compared to 29.0% on placebo [2][6] - GCA is a significant autoimmune disease that can lead to severe complications, and the new treatment option aims to reduce reliance on glucocorticoids, which have substantial side effects [2][7] Company Overview - AbbVie is committed to addressing unmet needs in immune-mediated diseases, as highlighted by the introduction of RINVOQ for GCA [2][31] - The company has a strong focus on rheumatology, having developed multiple therapies for various autoimmune conditions [31][32] Clinical Trial Insights - The SELECT-GCA trial involved 428 patients and assessed the efficacy and safety of RINVOQ in combination with a corticosteroid taper regimen [6][2] - The trial's results support the potential for RINVOQ to provide sustained remission in GCA patients, which is a significant advancement in treatment options [2][6] Market Implications - The approval of RINVOQ for GCA expands AbbVie's portfolio in the rheumatology space, potentially increasing market share and revenue from this therapeutic area [1][2] - The introduction of RINVOQ may shift treatment paradigms for GCA, offering a new alternative to traditional glucocorticoid therapies [2][7]

Core 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].