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# Dupixent Meets Key Phase 3 Endpoints: Regeneron
- URL: https://www.fdaweb.com/dupixent-meets-key-phase-3-endpoints-regeneron/
- Published: 2023-03-23T12:00:00.000Z
- Updated: 2026-09-14T18:21:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154055

Regeneron and Sanofi say a Phase 3 trial of Dupixent (dupilumab) evaluating the investigational use of the drug compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease (COPD) and evidence of type 2 inflammation met all key primary and secondary endpoints. A Regeneron [statement](https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-demonstrates-potential-become-first-biologic?ref=fdaweb.com) says Dupixent is the only biologic to demonstrate a clinically meaningful and highly significant reduction in moderate or severe acute exacerbations of COPD over 52 weeks while also demonstrating significant improvements in lung function, quality of life, and COPD respiratory symptoms.

The statement says the safety results were generally consistent with the drug’s known safety profile in its approved indications. In the U.S., Dupixent is indicated for treating some children and adults with atopic dermatitis, for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid-dependent asthma in some children and adults, with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis, to treat some children and adults with eosinophilic esophagitis, and to treat adults with prurigo nodularis.