This expands the previous approval in Japan in this indication for patients aged 12 years and older.
The approval in Japan is based on data from the overall population and those with a type 2 inflammation phenotype (defined by raised blood eosinophils and/or fractional exhaled nitric oxide) in VOYAGE (NCT02948959), a global phase 3 study evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.
Additionally, data from EXCURSION (NCT03560466), an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE study, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations (by 54% to 65%, p<0.0001) and improved lung function (by 4.68% to 5.32%, p=0.0012, p=0.0009 and p=0.0036, respectively) in the overall population, those with type 2 inflammation , and those with raised blood eosinophils, compared to placebo.
In the sub-study of Japanese pediatric patients, Dupixent improved lung function from baseline at 12 weeks and resulted in a low rate of severe asthma exacerbations over one year.
Asthma is one of the most common chronic diseases in children. Despite treatment with current standard-of-care inhaled corticosteroids and bronchodilators, children may continue to experience serious symptoms such as coughing, wheezing, and difficulty breathing. Additionally, impaired lung function in young children can have potentially long-lasting impacts such as reduced lung growth and persistent airway obstruction, if not addressed early. Patients also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled asthma can interfere with day-to-day activities, like sleeping, attending school, and playing sports.
In addition to asthma, Dupixent is approved in Japan in certain patients with atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD). Dupixent has been approved in 50 countries around the world for the treatment of asthma in children aged 6 to 11 years.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.