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# Dupixent Approved for COPD Add On
- URL: https://www.fdaweb.com/dupixent-approved-for-copd-add-on/
- Published: 2024-09-27T12:00:00.000Z
- Updated: 2026-09-14T14:42:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157876

FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.

Approval is based on data from two landmark pivotal Phase 3 studies ([BOREAS](https://www.news.sanofi.us/2023-03-23-Dupixent-R-demonstrates-potential-to-become-first-biologic-to-treat-COPD-by-showing-significant-reduction-in-exacerbations-in-pivotal-trial?ref=fdaweb.com) and [NOTUS](https://www.sanofi.com/en/media-room/press-releases/2023/2023-11-27-06-30-00-2785836?ref=fdaweb.com)) that evaluated the efficacy and safety of Dupixent compared to placebo in adults currently on maximal standard-of-care inhaled, according to the companies. They say that patients in the studies who received Dupixent saw the following:

- 30% and 34% reduction in the annualized rate of moderate or severe COPD exacerbations at Week 52, the primary endpoint
- 74mL and 68mL improvements in post-bronchodilator forced expiratory volume (FEV1) from baseline at Week 12 compared to placebo
- 51% response in health-related quality of life measures in both trials compared to 43% and 47% with placebo at Week 52

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, according to the companies. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and prurigo nodularis.