Dupixent® (dupilumab) Late-Breaking Data from NOTUS Confirmatory Phase 3 COPD Trial Presented at ATS and Published in The New England Journal of Medicine
TARRYTOWN, N.Y. and PARIS, May 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented late-breaking data from the NOTUS Phase 3 trial evaluating the investigational use of Dupixent® (dupilumab) as an add-on maintenance treatment in adults with uncontrolled COPD on maximal standard-of-care inhaled therapy (nearly all on triple therapy) and evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL). The NOTUS trial confirmed the positive results demonstrated in the landmark Phase 3 BOREAS trial, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM).
- The NOTUS trial confirmed the positive results demonstrated in the landmark Phase 3 BOREAS trial, with its data presented at a late-breaking session of the 2024 American Thoracic Society (ATS) International Conference and simultaneously published in the New England Journal of Medicine (NEJM) .
- “In NOTUS, dupilumab reduced exacerbations by a magnitude never seen before with an investigational biologic in a Phase 3 COPD clinical trial.
- These comprehensive results reinforce that, if approved, dupilumab could provide a first-of-its-kind medical advancement for the COPD community.”
As presented and published, the NOTUS trial met its primary and key secondary endpoints. - AEs more commonly observed with placebo than Dupixent included COPD (7.8% placebo, 4.9% Dupixent).