AbbVie Seeks FDA and EMA Approval for Upadacitinib to Treat Giant Cell Arteritis

NORTH CHICAGO, Ill., July 12, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to approve upadacitinib (RINVOQ®; 15 mg, once daily) for a new indication: treating adult patients with giant cell arteritis (GCA).

GCA is an autoimmune condition affecting medium and large arteries, which can lead to symptoms like headache, jaw pain, and vision changes, including sudden and irreversible vision loss.

According to Roopal Thakkar, M.D., AbbVie's executive vice president of research and development and chief scientific officer, there are currently limited approved treatments for GCA. Most patients rely on glucocorticoids, but many struggle to stop using them without their symptoms returning. Dr. Thakkar stressed the need for maintaining remission and minimizing glucocorticoid use in GCA treatment.

The applications to the FDA and EMA are backed by data from the SELECT-GCA Phase 3 study, which assessed the safety and effectiveness of upadacitinib in treating GCA.