In a groundbreaking development, Dupixent® (dupilumab) has been approved in Japan for children aged 6 to 11 years with bronchial asthma, offering hope to those with severe or refractory disease. This approval is based on a global Phase 3 program demonstrating Dupixent's remarkable efficacy in reducing exacerbations by 54% to 65% and improving lung function by 4.68% to 5.32% compared to placebo. But here's where it gets controversial: Dupixent is the first and only biologic medicine to show improved lung function in this young age group in a randomized Phase 3 trial, targeting IL-4 and IL-13, key drivers of type 2 inflammation. This approval expands Dupixent's reach in Japan, previously approved for patients aged 12 and older with the same condition.
The approval is supported by data from the VOYAGE trial, a global Phase 3 study, and its open-label extension, EXCURSION, which included a sub-study of Japanese pediatric patients. Dupixent significantly reduced severe exacerbations and improved lung function in various patient groups, including those with type 2 inflammation and raised blood eosinophils. In the Japanese sub-study, Dupixent improved lung function and reduced severe asthma exacerbations over one year. Common side effects included injection site reactions and fever.
Asthma is a prevalent chronic disease in children, and despite standard treatments, many continue to experience severe symptoms. Early intervention is crucial to prevent long-term lung damage. Dupixent is approved in Japan for various conditions, including atopic dermatitis, chronic rhinosinusitis with nasal polyposis, and more. It's available as a pre-filled syringe or pen and is administered subcutaneously every two or four weeks, depending on weight. Regeneron's VelocImmune® technology, a genetically engineered mouse platform, played a pivotal role in developing Dupixent, a fully human monoclonal antibody.
Dupixent has received approvals in over 60 countries for various indications, treating over 1.3 million patients globally. Regeneron's VelocImmune technology has been instrumental in creating a significant portion of FDA-approved fully human monoclonal antibodies, including Dupixent. The technology utilizes a genetically humanized mouse to produce optimized antibodies. Regeneron and Sanofi are jointly developing dupilumab, which has been studied in over 60 clinical trials involving more than 10,000 patients with chronic diseases driven by type 2 inflammation. Dupilumab is being investigated for additional indications, such as chronic pruritus of unknown origin, in Phase 3 trials.
Dupixent is a prescription medicine used for various conditions, with specific age and weight requirements. It is not a rescue medicine for sudden breathing problems and should not be used to treat other forms of hives. Important safety information includes warnings for allergic reactions, eye problems, blood vessel inflammation, psoriasis, and joint pain. Common side effects vary depending on the condition being treated. Patients should inform their healthcare providers about all medications and medical conditions before using Dupixent. Regeneron, a leading biotechnology company, is committed to translating science into life-transforming medicines. Sanofi, an AI-powered biopharma company, is dedicated to improving lives through innovative medicines and vaccines. Both companies are shaping the future of medicine through cutting-edge research and development.
