EMA Recommends Approval of AbbVie’s Upadacitinib for Giant Cell Arteritis

AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq; 15 mg, once daily) for the treatment of adult patients with GCA. The final European Commission decision is expected in the first half of 2025. If approved, upadacitinib would be the first and only oral advanced therapy for adults living with GCA.

""Giant cell arteritis is an inflammatory disease that, if left untreated, can lead to severe outcomes like blindness, stroke or aortic aneurysm,"" said Prof. Dr. med. Wolfgang Schmidt, M.D., MACR, Waldfriede Hospital, Department of Rheumatology, Berlin, Germany, and SELECT-GCA trial investigator. ""This positive opinion recognizes the unmet need for adults living with giant cell arteritis, and I look forward to the European Commission's final decision.""

The CHMP positive opinion is supported by data from the pivotal phase 3 SELECT-GCA clinical trial evaluating the efficacy and safety of upadacitinib in adults 50 years and older with GCA. In the first study period, patients were randomized to receive upadacitinib 7.5 mg or 15 mg in combination with a 26-week corticosteroid taper regimen or placebo in combination with a 52-week corticosteroid taper regimen.

During the 52-week, placebo-controlled period, the safety profile of upadacitinib was generally consistent with that observed in other approved indications.

""The CHMP's positive opinion for upadacitinib for adults living with giant cell arteritis is an important step toward our goal of improving outcomes for patients suffering with this disease,"" said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. ""We are committed to advancing the standards of care for immune-mediated diseases and addressing unmet patient needs, today and in the future.""

Rinvoq is approved in the European Union (EU) for the treatment of adults with radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and adults and adolescents with atopic dermatitis. Use of upadacitinib in GCA is not currently approved in the EU.

Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries, characterized by granulomatous inflammation of the three-layered vessel wall, which affects temporal and other cranial arteries as well as the aorta and other large arteries. GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent loss of vision. It is the most common vasculitis affecting adults in western countries. White women over the age of 50 – most commonly between the ages of 70 and 80 years – have the highest risk of developing giant cell arteritis. Although women are more likely than men to develop GCA, research suggests that men are more likely to have ocular manifestations with their disease.

SELECT-GCA (M16-852) is a phase 3, multicenter, randomized, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consists of two periods. The first period, which is reported in this release, evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen compared to placebo in combination with a 52-week corticosteroid taper regimen. In addition, the study assessed the safety and tolerability of upadacitinib in these patients. The second period will evaluate the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in participants who achieved sustained remission in the first period.

Discovered and developed by AbbVie scientists, Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human cellular assays, Rinvoq preferentially inhibits signaling by JAK1 or JAK 1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2. Upadacitinib (Rinvoq) is being studied in phase 3 clinical trials for alopecia areata, giant cell arteritis, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science that improves our understanding of promising new pathways and targets, ultimately helping more people living with rheumatic diseases reach their treatment goals.

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

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