Dupixent is already a blockbuster therapy for a range of immune-mediated diseases, but the Food and Drug Administration’s approval of the drug for chronic obstructive pulmonary disease greatly expands its reach — and could give it an edge over rival treatments in development.
The FDA decision, announced Friday, was based on a pair of late-stage trials that found Dupixent helped patients with the chronic lung condition, reducing the rate of flare-ups and improving their breathing. These studies also found that the drug was generally safe and well-tolerated.
The drug was cleared for use in adults whose COPD symptoms aren’t under control and whose disease is driven by eosinophils, a type of immune cell that can contribute to inflammation. There are 300,000 such people in the U.S., according to Regeneron and Sanofi, which jointly developed Dupixent.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in