1. AbbVie received positive opinion from EMEA for upadacitinib to treat GCA. 2. If approved, it becomes the sole oral therapy for adult GCA patients. 3. The final decision from the European Commission expected in 2025. 4. The treatment addresses a significant unmet need for GCA patients. 5. Positive clinical trial results support the approval recommendation.
The positive opinion for upadacitinib may boost ABBV’s stock due to anticipated revenue.
The news indicates a potential new revenue stream and strengthens ABBV's market position.
Approval could lead to immediate sales and market entry within 2025.
AbbVie (NYSE: ABBV) today 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.
*Sustained remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52 and adherence to the protocol-defined steroid taper over the course of the study term. †Sustained complete remission is defined as having an absence of GCA signs and symptoms from week 12 through week 52, adherence to the protocol-defined steroid taper, and normalization of both erythrocyte sedimentation rate and high-sensitivity C-reactive protein from week 12 through week 52.
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.
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.
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.
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis, and adults with moderately to severely active ulcerative colitis and Crohn's disease. RINVOQ may be used as monotherapy or in combination with conventional therapy. Contraindications and special warnings for use are outlined, including serious infections, hypersensitivity reactions, and gastrointestinal perforations.
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