AbbVie (NYSE: ABBV) 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.3,4
“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 Roopal Thakkar, 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 announced results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of upadacitinib in patients with GCA.
