Janus Kinase (JAK) inhibitor

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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]