The FDA has approved AbbVie’s RINVOQ (upadacitinib) for the treatment of giant cell arteritis, making it the ninth approved indication for the drug. This also marks the first time an oral JAK inhibitor has been approved for this prevalent form of vasculitis in Western countries. RINVOQ’s approval has sparked competition among other pharmaceutical companies in the giant cell arteritis market.
New York, USA, June 12, 2025 (GLOBE NEWSWIRE) — Giant-cell Arteritis Market Heats up with AbbVie’s RINVOQ Approval | DelveInsight
The FDA has approved AbbVie’s RINVOQ (upadacitinib) for the treatment of giant cell arteritis, making it the ninth approved indication for the drug. This also marks the first time an oral JAK inhibitor has been approved for this prevalent form of vasculitis in Western countries. RINVOQ’s approval has sparked competition among other pharmaceutical companies in the giant cell arteritis market.
Giant-cell arteritis, also known as “Temporal Arteritis,” is an inflammation of the arterial walls. It primarily affects arteries in the head, especially those near the temples, which is why it is often called temporal arteritis. In this condition, the temporal arteries, located on the sides of the head just in front of the ears, become inflamed. This inflammation causes the arteries to narrow, leading to reduced blood flow.
According to DelveInsight’s analysis, patients over 80 years old represented the largest group of those living with giant-cell arteritis in the 7MM during 2023. The primary aim of treatment is to prevent serious complications, such as blindness. The standard therapy involves administering high doses of corticosteroids like prednisone, and prompt treatment is crucial to avoid vision loss or stroke.
Learn more about the GCA treatment @ New Treatment for Giant-Cell Arteritis
ACTEMRA/ROACTEMRA (tocilizumab) is a pioneering anti-IL-6 receptor (aIL-6R) therapy. Interleukin-6 (IL-6) is thought to be a major contributor to the inflammatory processes underlying rheumatoid arthritis (RA) and other autoimmune inflammatory diseases. By binding to and blocking the IL-6 receptor, ACTEMRA/ROACTEMRA helps reduce the activity of IL-6, leading to relief from joint pain, swelling, and other inflammation-related symptoms. The therapy is also approved for several other conditions, including pediatric juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), Giant-Cell Arteritis, and cytokine release syndrome (CRS) caused by CAR-T cell therapy.
In September 2017, Roche announced that the European Commission (EC) approved ACTEMRA/ROACTEMRA for treating giant-cell arteritis, marking it as the first approved treatment for this condition in Europe. The decision was supported by results from the Phase III GiACTA study, which demonstrated that a weekly dose of the drug, combined with a six-month steroid taper, significantly improved sustained remission rates at one year, compared to steroid tapering alone.
Later, in November 2018, Roche reported that the U.S. FDA approved the ACTPen autoinjector (162 mg/0.9 mL) as a new formulation of ACTEMRA for adult patients with giant-cell arteritis, offering an additional, more convenient administration option.
Recently, in April 2025, AbbVie announced that the FDA had approved RINVOQ (upadacitinib) 15 mg, taken once daily, for treating adults with giant cell arteritis. This follows the recent marketing authorization granted by the European Commission for the same indication in adult patients.
These approvals are based on data from the pivotal Phase 3 SELECT-GCA trial, which achieved its primary endpoint of sustained remission. Specifically, 46.4% of patients treated with RINVOQ 15 mg alongside a 26-week steroid taper reached sustained remission between weeks 12 and 52, compared to 29.0% of those on placebo with a 52-week taper (p=0.002).
Throughout the 52-week, placebo-controlled study period, RINVOQ’s safety profile remained broadly consistent with its established safety in other approved uses.
Find out more on FDA-approved GCA drugs @ Giant-Cell Arteritis Treatment Options
Productive pharmacologic options for managing the most prevalent and most disabling phases of Giant-Cell Arteritis are minimal. Treatments that work in this disorder are scarce; therefore, new treatments are desperately needed. Some companies like Novartis (COSENTYX; secukinumab) and CSL/Kiniksa Pharmaceuticals (Mavrilimumab), among others, have initiated clinical trials that investigate new treatment options.
Discover which therapies are expected to grab major GCA market share @ Giant-Cell Arteritis Market Report
COSENTYX (secukinumab) is an injectable, fully human monoclonal antibody developed by Novartis Pharmaceuticals that targets and blocks interleukin-17A (IL-17A), a cytokine implicated in various immune-related disorders. It has received approval in both the United States and European Union for treating moderate-to-severe plaque psoriasis, active ankylosing spondylitis (AS) in adults, active non-radiographic axial spondyloarthritis (nr-axSpA), and active psoriatic arthritis (PsA) in adults.
Secukinumab is an IgG1 monoclonal antibody that specifically binds to IL-17A, preventing its interaction with the IL-17 receptor. IL-17A plays a key role in regulating immune and inflammatory responses. By blocking this cytokine, secukinumab helps reduce the production of proinflammatory cytokines and chemokines.
Novartis has completed a Phase II clinical trial for secukinumab in Giant-Cell Arteritis and is currently advancing the drug through Phase III trials for this indication.
Discover more about drugs for GCA in development @ Giant-Cell Arteritis Clinical Trials
The anticipated launch of these emerging therapies for GCA are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GCA market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for GCA is expected to grow from USD 960 million in the 7MM in 2023 at a significant CAGR by 2034. The growth of the giant-cell arteritis market is expected to be mainly driven by the growing geriatric population, the rise in the prevalence of cardiovascular disorders, technological advancements in the healthcare industry, and others.
DelveInsight’s latest published market report, titled as Giant-Cell Arteritis Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GCA country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market’s underlying potential. The GCA market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:
- Total Prevalent Cases of Giant-Cell Arteritis
- Total Subtype-specific Cases of Giant-Cell Arteritis
- Total Age group-specific Cases of Giant-Cell Arteritis
- Total Clinical Manifestation-specific Cases of Giant-Cell Arteritis
- Total Treated Cases of Giant-Cell Arteritis
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GCA market. Highlights include:
- 10-year Forecast
- 7MM Analysis
- Epidemiology-based Market Forecasting
- Historical and Forecasted Market Analysis upto 2034
- Emerging Drug Market Uptake
- Peak Sales Analysis
- Key Cross Competition Analysis
- Industry Expert’s Opinion
- Access and Reimbursement
Download this GCA market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs’ opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GCA market. Also, stay abreast of the mitigating factors to improve your market position in the GCA therapeutic space.
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Giant-Cell Arteritis Pipeline
Giant-Cell Arteritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key giant-cell arteritis companies, including Novartis, AbbVie, XOMA, Kiniksa Pharmaceuticals, Ltd., Eli Lilly and Company, Janssen Biotech, Dr Reddys Laboratories, among others.
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