Press Release: Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD study presented at ATS and published in NEJM

Core Insights - The NOTUS phase 3 study confirms Dupixent's efficacy in reducing COPD exacerbations by 34% and improving lung function, marking it as a potential first new treatment for COPD in over a decade [1][2][3] Study Results - Dupixent significantly reduced moderate or severe COPD exacerbations by 34% over 52 weeks compared to placebo (p<0.001), meeting the primary endpoint [2][3] - Patients on Dupixent showed more than two times greater improvement in lung function (pre-bronchodilator FEV1) at 12 weeks (139 mL vs. 57 mL; p<0.001) and maintained improvement at week 52 (115 mL vs. 54 mL; p=0.018) [2][3] - Health-related quality of life improvements and reductions in respiratory symptom severity were also observed, although these were numerically greater rather than statistically significant [2] Safety Profile - The overall rates of adverse events (AEs) were similar between Dupixent (67%) and placebo (66%) [3] - Common AEs for Dupixent included COVID-19 (9.4%), nasopharyngitis (6.2%), and headache (7.5%), while COPD-related AEs were more common in the placebo group (7.8%) [3] Regulatory Status - Dupixent is under Priority Review by the US FDA for use in uncontrolled COPD with type 2 inflammation, with a target action date of June 27, 2024 [3] - Regulatory submissions are also under review in the EU and China, with ongoing discussions with other regulatory authorities [3] Background on COPD - COPD is a progressive respiratory disease with significant health and economic burdens, affecting approximately 300,000 people in the US with uncontrolled symptoms and type 2 inflammation [5]