FDA Approves Regeneron/Sanofi's Blockbuster Dupixent For Smoker's Lung Disease

Core Insights - The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, marking it as the first biologic medicine for this indication in the U.S. [1][5] - The approval is supported by data from two Phase 3 trials (BOREAS and NOTUS) that demonstrated significant efficacy and safety compared to placebo [2][5] Efficacy and Safety Data - In the BOREAS trial, patients receiving Dupixent showed a 30% reduction in the annualized rate of moderate or severe COPD exacerbations, while the NOTUS trial showed a 34% reduction over 52 weeks [3] - Improvements in post-bronchodilator FEV1 were observed, with increases of 74mL in BOREAS and 68mL in NOTUS from baseline at week 12, sustained at 52 weeks [3] - A health-related quality of life measure indicated a 51% response in both trials for Dupixent compared to 43% and 47% for placebo at 52 weeks [3] Market Context - Approximately 300,000 individuals in the U.S. suffer from inadequately controlled COPD with an eosinophilic phenotype, which is associated with a ~30% increase in exacerbations and a higher risk of COPD-related re-hospitalizations [4] - Following the FDA approval, Regeneron Pharmaceuticals (REGN) stock rose by 2.86% to $1,069.75, while Sanofi (SNY) stock increased by 1.49% to $57.85 [5]