CHMP Endorses Upadacitinib for Adult Giant Cell Arteritis Treatment

NORTH CHICAGO, Ill., Feb. 28, 2025 – AbbVie has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a favorable recommendation for the approval of upadacitinib (RINVOQ®; 15 mg, once daily) for treating adult patients with giant cell arteritis (GCA). A decision from the European Commission is anticipated in the first half of 2025, and if approved, upadacitinib would stand as the first oral advanced therapy available for adults managing GCA.

Giant cell arteritis is an autoimmune condition that inflames the large and medium cranial arteries, leading to potentially serious symptoms such as headaches, jaw pain, and vision loss. It is the most common form of vasculitis in adults in Western countries, predominantly affecting white women over 50 years old. Despite being more prevalent in women, men with GCA tend to experience more ocular symptoms.

The positive opinion from CHMP is based on the results from the Phase 3 SELECT-GCA clinical trial. This trial assessed the efficacy and safety of upadacitinib in adults aged 50 and older with GCA. Participants were divided to receive either 7.5 mg or 15 mg of upadacitinib alongside a 26-week corticosteroid taper regimen or a placebo with a 52-week corticosteroid taper regimen. The trial achieved its primary endpoint of sustained remission—defined by the absence of GCA signs and symptoms over several weeks—and met key secondary endpoints such as reduction in disease flares and lowered cumulative steroid exposure.

The safety profile of upadacitinib during the study's 52-week, placebo-controlled period was consistent with other approved indications. This development marks an important step for AbbVie in addressing the needs of patients with giant cell arteritis and advancing care standards for autoimmune diseases.

Upadacitinib, marketed as RINVOQ, is already approved in the European Union for treating various conditions, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ulcerative colitis, Crohn's disease, and atopic dermatitis. However, its use in treating GCA is not yet approved in the EU.

The SELECT-GCA trial, a multicenter, randomized, double-blind study, involves 428 patients and is divided into two periods. The first period, which has been reported, compared the safety and efficacy of upadacitinib with a corticosteroid taper regimen against a placebo. The subsequent period will explore the effects of continuing or discontinuing upadacitinib in patients who achieved sustained remission in the initial phase.

Upadacitinib is a selective and reversible JAK inhibitor under investigation for several immune-mediated inflammatory diseases, including alopecia areata, Takayasu arteritis, systemic lupus erythematosus, hydradenitis suppurativa, and vitiligo. It has shown functional selectivity in inhibiting JAK1 or JAK 1/3 pathways in human cellular assays.

AbbVie has been committed to improving care for individuals with rheumatic diseases for over 20 years, focusing on transformative therapies that enhance understanding of promising pathways and targets. The approval of upadacitinib for GCA represents a significant milestone in AbbVie's mission to deliver innovative solutions for serious health issues and to address the medical challenges of tomorrow.