EU Greenlights First Targeted COPD Therapy, Dupixent

Sanofi and Regeneron have received European Union approval for their Dupixent injection for the treatment of chronic obstructive pulmonary disease (COPD), a condition primarily affecting cigarette smokers. This approval marks a rare instance of the EU clearing a drug faster than the United States, where the U.S. Food and Drug Administration (FDA) has delayed its review by three months to September 27 due to the need for additional efficacy data. The drug is already approved in many countries for various immune system-related conditions such as asthma and eczema.

The European Commission's decision to approve Dupixent was based on two landmark Phase 3 trials that demonstrated the drug's ability to significantly reduce exacerbations, improve lung function, and enhance health-related quality of life in COPD patients with raised blood eosinophils. This approval represents the first new treatment approach for COPD in over a decade and is expected to benefit approximately 220,000 adults in the EU. Additional regulatory submissions for Dupixent are currently under review in the U.S., China, and Japan.