CHMP positive opinion for upadacitinib (Rinvoq) for the treatment of adults with giant cell arteritis – Abbvie

AbbVie announced that the EMA’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 (Giant  Cell Arteritis). 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, 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 III 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.

SELECT-GCA (M16-852) is a Phase III, multicenter, randomized, double-blind placebo-controlled study (NCT03725202) 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. Top-line results of the study were shared in April 2024.

“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 Dr. Kori Wallace,  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.

See citation- Blockmans D, Penn SK, Setty A, et al. LBA0001 Efficacy and safety of upadacitinib in patients with giant cell arteritis (SELECT-GCA): a double-blind, randomized controlled phase 3 trial. Ann Rheum Dis. 2024; 83(suppl 1):232-233. doi:10.1136/annrheumdis-2024-eular.LBA25