French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose condition is not controlled by existing therapies.

The approval is based on results from the BOREAS phase 3 study, which demonstrated that Dupixent significantly reduced exacerbations and improved lung function in patients with elevated blood eosinophils. Safety results were consistent with Dupixent's known profile, with injection site reactions being the most common adverse event.

This approval marks the first new treatment approach for COPD in Japan in over a decade and adds to Dupixent's portfolio of indications, which includes atopic dermatitis, asthma and other chronic diseases with underlying type 2 inflammation. Dupixent is now approved for COPD in over 45 countries, including the European Union, China and the United States.

Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.