Dupixent (dupilumab) approved in Japan for children aged 6 to 11 years with bronchial asthma – Sanofi

The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of bronchial asthma in children aged 6 to 11 years with severe or refractory disease whose symptoms are inadequately controlled with existing therapy. 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 III 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. The treatment-related adverse events most commonly reported with Dupixent were injection site reactions (erythema, edema, and induration) in VOYAGE and fever, oral herpes, eosinophilia, and injection site reactions (erythema and induration) in EXCURSION.

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.

About Dupixent
Dupixent (dupilumab) is available in Japan as a 200 mg or 300 mg pre-filled syringe or pre-filled pen and is now available for children aged 6 to 11 years with asthma. Dupixent is intended for injection under the skin (subcutaneous injection) and is given every two or four weeks based on weight. It can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home.