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AbbVie Submits Application for Upadacitinib in Takayasu Arteritis Treatment

AbbVie, a global biopharmaceutical company based in Tokyo, has announced today its application for additional approval of Upadacitinib as a treatment for Takayasu arteritis in Japan. Upadacitinib is an orally administered small molecule Janus kinase (JAK) inhibitor, which has already received approval for eight different indications, including rheumatoid arthritis, in Japan.

Understanding Takayasu Arteritis

Takayasu arteritis is a large vessel vasculitis characterized by inflammation of the aorta and its major branches, including the coronary arteries and pulmonary arteries. The disease is currently categorized as a specified intractable disease, which poses significant diagnostic and therapeutic challenges. The inflammation in vascular walls leads to various complications like narrowing, occlusion, and dilation of blood vessels, ultimately resulting in impaired blood flow and damage to vital organs like the heart, brain, kidneys, and lungs.

As of the end of the fiscal year 2024, the number of patients diagnosed with Takayasu arteritis in Japan is estimated to be around 5,000 according to the Ministry of Health, Labour and Welfare's statistics, with approximately 200 to 300 new cases emerging every year. Notably, about 90% of patients are women, and the condition predominantly manifests around the age of 20.

Currently, the recommended treatments for Takayasu arteritis include corticosteroids and IL-6 inhibitors; however, options remain limited, leading to cases where corticosteroid reduction results in relapses. Even patients who achieve temporary remission through traditional immunosuppressive therapies experience high relapse rates. Additionally, some patients encounter complications that make treatment extremely difficult.

Given these circumstances, there is a compelling unmet medical need for new treatment options for patients suffering from Takayasu arteritis. In response to this need, AbbVie has submitted its request for additional approval of Upadacitinib based on the outcomes of the international phase 3 trial M19-052.

Details of the M19-052 Study

The M19-052 study is a randomized, double-blind, placebo-controlled, multi-center international phase 3 trial designed to evaluate the efficacy and safety of Upadacitinib in patients with Takayasu arteritis. For more detailed information regarding this study, please refer to clinicaltrials.gov (NCT04161898).

More About Upadacitinib

Developed by AbbVie, Upadacitinib is a selective small molecule JAK inhibitor aimed at treating multiple immune-mediated diseases. This drug demonstrates a degree of functional selectivity, preferentially inhibiting signaling through JAK1 or JAK1/3 compared to cytokine receptors that transmit signals through JAK2 pairs. Approved in Japan in January 2020, Upadacitinib has since gained approvals for several other indications such as psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, and more recently for Crohn's disease and giant cell arteritis.

AbbVie’s Commitment

AbbVie’s mission revolves around addressing and innovating solutions for pressing health challenges. Its portfolio spans important areas such as immunology, neuroscience, oncology, and the aesthetics segment. In Japan, AbbVie focuses on developing products in immune diseases, liver diseases, neuropsychiatric disorders, cancer, and eye care, among others.

For more information about AbbVie, you can visit www.abbvie.com and follow them on LinkedIn, Facebook, Instagram, X, and YouTube.

Please take note that information provided here reflects the current understanding and ongoing research related to Takayasu arteritis and Upadacitinib, with further updates anticipated as new findings emerge.