Dupixent Approved in Japan as First Biologic for COPD

Sanofi-Aventis announced that Japan's Ministry of Health, Labour and Welfare has approved Dupixent (dupilumab) as the first biological treatment for chronic obstructive pulmonary disease (COPD) in adults inadequately controlled by existing therapies. This decision follows approvals in the EU, China, and the US.

The approval is based on phase 3 trials, which demonstrated Dupixent's efficacy in reducing exacerbations and improving lung function in COPD patients with elevated eosinophils. The safety profile was consistent with previous findings, with injection site reactions being the most common adverse event.

In addition to COPD, Dupixent is approved in Japan for conditions like atopic dermatitis and asthma. Globally, Dupixent is approved in over 45 countries for COPD, marking a significant step in the treatment of chronic diseases with underlying type 2 inflammation.