AbbVie, Inc. (ABBV) has announced the submission of applications to both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication of upadacitinib (RINVOQ 15 mg, once daily). The proposed indication is for the treatment of adult patients suffering from giant cell arteritis (GCA).
GCA, an autoimmune condition affecting medium and large arteries, can lead to symptoms such as headaches, jaw pain, and vision changes, including sudden and irreversible vision loss. These regulatory submissions are backed by data from the previously reported SELECT-GCA Phase 3 study, which assessed the safety and efficacy of upadacitinib in GCA patients.
