RINVOQ (upadacitinib)

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Giant-Cell Arteritis Market Heats up with AbbVie's RINVOQ Approval | DelveInsight
GlobeNewswire News Room· 2025-06-12 17:00
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]
RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA)
Prnewswire· 2025-04-29 11:30
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]