Regeneron, Sanofi get marketing authorization for Dupixent from MHLW in Japan

Regeneron (REGN) and Sanofi (SNY) announced that the Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent 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 in VOYAGE, a global Phase 3 trial evaluating Dupixent in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. Additionally, data from EXCURSION, an open-label extension of VOYAGE that included a sub-study of exclusively Japanese pediatric patients supported the approval. In the VOYAGE trial, Dupixent added to standard-of-care asthma therapy significantly reduced severe exacerbations and improved lung function 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 in VOYAGE and fever, oral herpes, eosinophilia and injection site reactions in EXCURSION.