Rinvoq Approved in Japan
2025-06-24 05:59:19

AbbVie Receives Approval for Rinvoq to Treat Giant Cell Arteritis in Japan

AbbVie Expands Treatment with Rinvoq for Giant Cell Arteritis in Japan



AbbVie, based in Minato City, Tokyo, has received additional regulatory approval for its Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib), as a treatment for adult patients with Giant Cell Arteritis (GCA) who have not responded adequately to existing therapies. This approval marks a significant step in providing new treatment options for a condition that affects many, particularly those over the age of 50.

Understanding Giant Cell Arteritis


Giant Cell Arteritis is an autoimmune disease characterized by inflammation of large and medium-sized arteries, particularly those in the head, such as the temporal arteries. It is recognized as a specified intractable disease in Japan, often diagnosed in individuals over 50 years, with women at a higher risk than men—about two to three times more likely to be affected. Common symptoms of GCA include severe headaches, jaw pain, and potential vision changes which can lead to permanent loss of sight.

Currently, GCA treatment primarily revolves around corticosteroids, which can alleviate symptoms. However, 30 to 50% of patients may experience symptom exacerbation after initial improvement. Long-term corticosteroid therapy is associated with various side effects, leading to the need for cautious management. If the existing treatments do not provide sufficient relief, there are serious risks including blindness, aortic aneurysm, stroke, and myocardial infarction.

This challenging landscape prompted AbbVie to further develop upadacitinib for GCA, providing this promising treatment option for patients.

Clinical Evidence Supporting Approval


The recent approval of Rinvoq is based on data from the international phase III clinical trial SELECT-GCA (M16-852), which included participants from Japan. This major trial demonstrates the efficacy and safety of upadacitinib in this specific patient population, offering hope for those struggling with inadequate responses to current treatment methods. For detailed information on the trial, visit clinicaltrials.gov (NCT03725202).

Comprehensive Treatment Options


With this new approval, Rinvoq now represents the eighth approved indication within Japan for the medication. Previously, it was recognized for various conditions, including rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, atopic dermatitis, ulcerative colitis, and Crohn’s disease. This extensive portfolio showcases AbbVie’s commitment to addressing significant unmet medical needs across multiple inflammatory and autoimmune conditions.

Rinvoq is an oral medication taken once daily, which prioritizes inhibiting signaling through the JAK1/3 pathway over JAK2, thereby offering targeted therapeutic action for immune-related disorders.

AbbVie’s Mission and Future Directions


AbbVie’s mission centers on solving urgent health challenges through innovative medicine. By focusing on areas such as immunology, oncology, and neurological disorders, AbbVie aims to improve the quality of life for individuals affected by chronic health issues. Further information about AbbVie’s work can be found on their websites and social media platforms, emphasizing their ongoing commitment to develop solutions that enhance patient wellbeing.

Given the newly expanded indication of Rinvoq, patients diagnosed with GCA now have another potential avenue for treatment that could improve their quality of life, highlighting the importance of ongoing research and development in the field of medicine.

Topics Health)

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