NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation
Data support the potential of Dupixent as the first new treatment approach in more than a decade and first-ever targeted therapy for COPD
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).
“In my more than 20 years of practice, there have been limited advancements for patients struggling with the debilitating effects of uncontrolled COPD, and too many patients experience a vicious cycle of exacerbations that can result in loss of lung function and greatly diminish their quality of life,” said Surya Bhatt, M.D., MSPH, Professor at the University of Alabama at Birmingham, Division of Pulmonary, Allergy, and Critical Care Medicine and a co-principal investigator of the trial. “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. All patients were on background maximal standard-of-care inhaled therapy (nearly all on triple therapy). Patients receiving Dupixent (n=470) experienced the following, compared to placebo (n=465):
- 34% reduction in moderate or severe COPD exacerbations over 52 weeks (p