AbbVie has submitted regulatory applications to both the FDA and the EMA for the approval of upadacitinib, branded Rinvoq, for treating giant cell arteritis (GCA) in adults.
The applications for the new indication are supported by data from the phase 3 SELECT-GCA study, which demonstrated that upadacitinib 15 mg, taken once daily in conjunction with a 26-week steroid taper regimen, met the primary endpoint of sustained remission from week 12 through week 52.
Giant cell arteritis is an autoimmune disease affecting medium and large arteries, leading to symptoms like headache, jaw pain, and vision changes, including sudden and permanent vision loss. Most patients rely on glucocorticoids, which many cannot discontinue without symptom recurrence.
Upadacitinib, a JAK inhibitor, was first approved in August 2019 for treating moderately to severely active rheumatoid arthritis. Since, the drug has been approved for treating various 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.
If approved for GCA, the drug will compete against Genentech's blockbuster Actemra (tocilizumab), the first drug approved specifically for treatment of GCA.
