Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype
Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and health-related quality of life compared to placebo
Dupixent is the leading biologic medicine for all of its FDA-approved indications in new-to-brand prescriptions, and the most prescribed biologic by pulmonologists in the U.S.
TARRYTOWN, N.Y. and PARIS, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the U.S. to treat these patients.