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.
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