#Japan #AbbVie #Minato-ku #Upadacitinib #Polyarticular JIA

AbbVie Seeks Additional Approval for Upadacitinib in Japan

AbbVie, headquartered in Minato-ku, Tokyo, led by President Thiago Campos Rodrigues, announced today that it has submitted an application for additional approval of Upadacitinib as a treatment for polyarticular course juvenile idiopathic arthritis (pcJIA) in Japan. This condition primarily affects children and requires effective management due to the lack of curative treatments currently available.

Juvenile idiopathic arthritis (JIA) is an autoimmune disease classified as a designated intractable disease in Japan. It generally manifests before the age of 16 and lasts for more than six weeks, presenting as chronic arthritis of unknown origin. JIA is categorized into seven distinct types according to the International League of Associations for Rheumatology (ILAR) classification criteria. Among these, pcJIA is defined as arthritis that affects five or more joints during its course and accounts for approximately 30% of all JIA cases.

Children and adolescents with pcJIA experience significant functional impairment, growth issues, joint deformities, and long-term disabilities. Typical symptoms include limping, morning stiffness, reduced activity levels, swollen joints, and difficulty with fine motor skills. Additionally, many young patients report depressive symptoms, especially in the case of pcJIA, often due to exacerbated pain and disability. Research indicates that over 45% of pcJIA patients may continue to suffer from active disease into adulthood, severely impacting their quality of life due to prolonged restrictions on physical activity.

The primary treatment goal for JIA patients is to achieve clinical remission, particularly in those with a long disease history, where maintaining low disease activity becomes a secondary goal. The introduction of biologic therapy has notably advanced the treatment options for pcJIA; however, there remain many patients who do not achieve remission or low disease activity and may become intolerant to current therapies or lose their responsiveness over time. Thus, there is still an unmet need for effective and tolerable new treatment options, particularly oral formulations that are preferable for pediatric patients.

In light of this pressing need, AbbVie has submitted its request for the additional approval of Upadacitinib for pcJIA. The application is based on the results of two international phase 1 trials: the M15-340 trial conducted in Japan and the M16-049 trial overseas.

Details of the M15-340 Trial

The M15-340 trial is an international, non-randomized, open-label phase 1 study designed to evaluate the pharmacokinetics, safety, and tolerability of Upadacitinib in patients with pcJIA aged 2 years to less than 18 years. The study consists of three parts. Part 1 involves two dosing groups, allowing patients who demonstrate benefits from the investigational drug and do not exhibit severe adverse effects to be enrolled in Part 2 for the evaluation of long-term safety and tolerability. Part 3 includes additional safety cohorts to assess ongoing safety measures. More detailed information about this trial can be found at clinicaltrials.gov (NCT03725007).

Insights from the M16-049 Trial

The M16-049 trial assesses the safety, pharmacokinetics, and tolerability of Upadacitinib in patients aged 2 to less than 12 years with atopic dermatitis (AD) and gathers information on the preference for the oral liquid formulation among pediatric patients. This study also comprises two parts, where participants who complete Part 1 may be enrolled in Part 2 for further evaluation. For more details, please visit clinicaltrials.gov (NCT03646604).

Based on interim analyses of pharmacokinetic data from both the pcJIA (M15-340 trial) and pediatric AD (M16-049 trial) studies, updated dosage recommendations for Upadacitinib within weight bands and doses for pcJIA patients have been established.

About Upadacitinib

Developed by AbbVie, Upadacitinib is a selective JAK inhibitor that has shown efficacy across multiple immune-mediated diseases. It preferentially blocks signaling through JAK1 or JAK1/3 compared to JAK2, demonstrating functional selectivity. In Japan, Upadacitinib has already received approval for eight indications, including rheumatoid arthritis—a decision reached in January 2020. Additional approvals followed for conditions such as psoriatic arthritis in May 2021, atopic dermatitis in August 2021, ankylosing spondylitis in May 2022, ulcerative colitis in September 2022, and most recently, Crohn’s disease and axial spondyloarthritis—expanding its therapeutic reach through 2025.

About AbbVie

AbbVie is committed to addressing critical health challenges by developing innovative pharmaceuticals that aim to improve individual lives. The company focuses on several key areas including immunology, oncology, neuroscience, eye care, and the aesthetics portfolio of Allergan Aesthetics. With ongoing efforts to enhance the quality of life for individuals facing these health issues, AbbVie maintains a commitment to research and development across various therapeutic areas. For more information, visit www.abbvie.com or its local website www.abbvie.co.jp and find them on social media platforms such as Facebook, Instagram, X (formerly Twitter), YouTube, and LinkedIn.