Pharmaceutical company AbbVie (NYSE:ABBV) announced on Friday that it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending the approval of upadacitinib (RINVOQ) for treating adults with giant cell arteritis (GCA).

A final decision from the European Commission is expected in the first half of 2025. If approved, upadacitinib would become the first oral advanced therapy for GCA.

The recommendation is based on data from the Phase 3 SELECT-GCA trial, which demonstrated that upadacitinib met the primary endpoint of sustained remission, along with key secondary endpoints such as reduced disease flares, lower cumulative steroid exposure, and complete remission. The trial included adults aged 50 and older who received either upadacitinib or placebo in combination with corticosteroid taper regimens.

GCA is a serious autoimmune disease that affects medium and large arteries, potentially leading to severe complications such as vision loss, stroke, or aortic aneurysm. The safety profile of upadacitinib in the trial was consistent with its use in other approved indications.

Upadacitinib is currently approved in the European Union for multiple inflammatory diseases, including rheumatoid arthritis, ulcerative colitis, Crohn's disease, and atopic dermatitis. Its use in GCA has not yet been approved in the region.