Regeneron, Sanofi announce Dupixent authorization 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 chronic obstructive pulmonary disease in adults whose disease is not adequately controlled with existing therapy. The approval in Japan was based on data from the landmark pivotal BOREAS Phase 3 trial. The trial evaluated Dupixent added to background maximal standard-of-care inhaled therapy in adults with uncontrolled COPD and elevated blood eosinophils. In the trial, Dupixent significantly reduced exacerbations and improved lung function compared to placebo. Safety results in the trial were generally consistent with the known safety profile of Dupixent in its approved indications. The adverse event most commonly reported with Dupixent was injection site reaction. Results from BOREAS and the replicate NOTUS Phase 3 trial were published in The New England Journal of Medicine. In addition to COPD, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis and chronic spontaneous urticaria. Dupixent for the treatment of COPD has been approved in more than 45 countries worldwide, including the 27 member countries of the European Union.