AbbVie has applied to the U.S. Food and Drug Administration and European Medicines Agency for approval of upadacitinib (RINVOQ®; 15 mg, once daily) to treat giant cell arteritis (GCA) in adults. GCA is an autoimmune disease affecting medium and large arteries, causing symptoms like headache, jaw pain, and vision changes, including sudden and permanent vision loss. Current treatment options are limited mainly to glucocorticoids, which many patients struggle to discontinue without symptoms returning.

Dr. Roopal Thakkar, AbbVie's Executive Vice President of Research and Development and Chief Scientific Officer, highlighted the need to achieve remission and reduce glucocorticoid use in managing GCA. The regulatory submissions are supported by findings from the Phase 3 SELECT-GCA study, which assessed upadacitinib's safety and efficacy in 428 patients. This study compared upadacitinib with a corticosteroid taper regimen against placebo with a longer taper regimen.

Giant cell arteritis (GCA), also known as temporal arteritis, predominantly affects Caucasian women over 50, with men more likely to experience ocular complications. Upadacitinib (RINVOQ®) is a JAK inhibitor developed by AbbVie, showing promising results across various immune-mediated inflammatory diseases. Ongoing Phase 3 trials are investigating its potential in conditions such as alopecia areata, hidradenitis suppurativa, and systemic lupus erythematosus.

AbbVie has a longstanding commitment to advancing rheumatology care, leveraging innovative science to explore new treatment pathways and improve outcomes for patients with rheumatic diseases. For more information, visit AbbVie's rheumatology initiatives.

 

Source: prnewswire.com

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