Globenewswire·2025-12-23 06:00Core Viewpoint - Sanofi and Regeneron's Dupixent has received approval in Japan for treating bronchial asthma in children aged 6 to 11 years, expanding its previous approval for patients aged 12 and older [1][4]. Group 1: Approval and Clinical Data - The approval is based on data from the VOYAGE global phase 3 study, which showed that Dupixent significantly reduced severe asthma exacerbations by 54% to 65% and improved lung function by 4.68% to 5.32% compared to placebo [2][8]. - Additional support for the approval came from the EXCURSION study, which included a sub-study of Japanese pediatric patients, demonstrating improved lung function and a low rate of severe exacerbations over one year [2][8]. Group 2: Asthma in Children - Asthma is a prevalent chronic disease in children, often leading to serious symptoms and impaired lung function, which can have long-lasting effects if not treated early [3]. - Uncontrolled asthma can disrupt daily activities such as sleeping, attending school, and playing sports [3]. Group 3: Dupixent Overview - Dupixent is a fully human monoclonal antibody that inhibits IL-4 and IL-13 signaling pathways, which are key drivers of type 2 inflammation [6][8]. - The drug is available in Japan as a 200 mg or 300 mg pre-filled syringe or pen, administered subcutaneously every two or four weeks based on weight [5]. Group 4: Broader Indications and Global Reach - In addition to asthma, Dupixent is approved for various conditions in Japan, including atopic dermatitis and chronic rhinosinusitis with nasal polyposis [4]. - Dupixent has received regulatory approvals in over 60 countries and is currently being used to treat more than 1.3 million patients globally [7].