**Regeneron and Sanofi’s Dupixent Approved in Japan for COPD, Marking First Biologic Treatment for the Disease**

On March 28, 2025, Regeneron Pharmaceuticals and Sanofi announced 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 disease is not adequately controlled by existing therapies. This approval marks the first-ever biologic medicine authorized in Japan for COPD and follows recent approvals in the U.S., EU, and China.

The decision was based on results from the pivotal Phase 3 BOREAS trial, which demonstrated that Dupixent significantly reduced exacerbations and improved lung function in adults with uncontrolled COPD and elevated eosinophil counts. The trial’s safety profile was consistent with previous Dupixent studies, with the most common adverse event being injection site reactions.

This approval adds COPD as the sixth indication for Dupixent in Japan, where it is also approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, and chronic spontaneous urticaria.

Dupixent, a fully human monoclonal antibody, blocks interleukin-4 and interleukin-13 signaling and is now approved in over 60 countries across a range of diseases driven by type 2 inflammation. Over one million patients worldwide have been treated with Dupixent to date.

The company also continues to evaluate itepekimab, an IL-33 inhibitor, in two Phase 3 trials for COPD. Regulatory submissions for other Dupixent indications, such as bullous pemphigoid and chronic pruritus, are in progress.

More information is available at [www.regeneron.com](https://www.regeneron.com) and [www.sanofi.com](https://www.sanofi.com).