Research & Development
Dupixent shows significant COPD exacerbation reduction in Phase 3 trial, accelerating FDA submission
27 November 2023 -

French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) reported on Monday that Dupixent (dupilumab) demonstrated a substantial 34% reduction in chronic obstructive pulmonary disease (COPD) exacerbations in its second Phase 3 trial, NOTUS.

The trial met its primary endpoint, confirming earlier results from the landmark BOREAS trial. Dupixent, a fully human monoclonal antibody targeting interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, rapidly and significantly improved lung function compared to placebo at 12 weeks.

With approximately 300,000 Americans facing uncontrolled COPD with type 2 inflammation, Dupixent's promising results position it as a potential first approved biologic for this serious disease. A supplemental Biologics License Application (BLA) submission is planned by end of 2023.

Earlier this year, the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Dupixent as an add-on maintenance treatment in adult patients with uncontrolled COPD associated with a history of exacerbations and an eosinophilic phenotype based on the positive results from BOREAS.

Dupixent is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.

Sanofi and Regeneron plan to submit data from both BOREAS and NOTUS trials to the FDA by year-end. The European Medicines Agency is reviewing a similar application, and discussions with other regulatory authorities globally are ongoing.