AbbVie pursues new use for blockbuster JAK inhibitor

AbbVie has filed applications with the FDA and EMA seeking approval for upadacitinib, marketed as Rinvoq, to be used in treating giant cell arteritis (GCA) in adults. This request is backed by results from the phase 3 SELECT-GCA study, demonstrating that a 15 mg dose of upadacitinib, administered daily alongside a 26-week steroid taper, achieved the primary goal of sustained remission from week 12 through week 52.

Giant cell arteritis is an autoimmune condition that affects medium and large arteries, resulting in symptoms such as headaches, jaw pain, and vision changes, potentially leading to sudden and permanent vision loss. Glucocorticoids are currently the primary treatment, but many patients struggle to cease their use without symptoms reappearing.

Upadacitinib, a JAK inhibitor, initially received approval in August 2019 for treating moderately to severely active rheumatoid arthritis. Since then, it has been approved for several other conditions, including psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, juvenile psoriatic arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease.

Should upadacitinib receive approval for GCA, it will enter a market currently dominated by Genentech's Actemra (tocilizumab), which was the first drug specifically approved for GCA treatment.