AbbVie Seeking FDA And EMA Approval For Upadacitinib In Giant Cell Arteritis

(RTTNews) - AbbVie, Inc. (ABBV) announced Friday 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. 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.