, /PRNewswire/ -- AbbVie (NYSE: ) today announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for upadacitinib (RINVOQ ; 15 mg, once daily) for the treatment of adult patients with giant cell arteritis (GCA).
GCA is an autoimmune disease of medium and large arteries and can cause headache, jaw pain, and changes in vision, including sudden and permanent loss of vision "Currently, there are few approved treatment options for patients with GCA. Most patients are managed with glucocorticoids, and many are unable to discontinue them without the recurrence of GCA symptoms," stated , M.D.
, executive vice president, research and development, and chief scientific officer, AbbVie. "We recognize the importance of maintaining remission and limiting the use of glucocorticoids in GCA." The regulatory submissions to the FDA and EMA are supported by previously results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.
SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two periods. The first period evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen.
In addition, the f.