Regeneron and Sanofi Receive FDA Approval for Dupixent in COPD with Type 2 Inflammation

Regeneron and Sanofi today announced that the FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with type 2 inflammation, as indicated by elevated blood eosinophil counts. This is the first biologic approved for COPD. In the Phase 3 BOREAS and NOTUS trials, Dupixent demonstrated statistically significant reductions in moderate-to-severe COPD exacerbations of 34% and 34% respectively compared to placebo. This approval expands Dupixent's use into COPD, providing a new treatment option for patients with this common respiratory disease.