Regeneron Pharmaceuticals (NASDAQ:REGN) and development partner Sanofi (NYSE:SNY) announce positive results from two Phase 3 clinical trials, SINUS-24 and SINUS-52, evaluating DUPIXENT (dupilumab) in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps. The studies met all primary and secondary endpoints.
Patients receiving DUPIXENT added to standard-of-care corticosteroid nasal spray experienced a 51% and 57% improvement, respectively, in nasal congestion/obstruction severity compared to a 15% and 19% improvement, respectively, with nasal spray alone (placebo).
Patients in the treatment group experienced a 27% and 33% respective reduction in nasal polyps score compared to 4% and 7%, respectively, for placebo.
DUPIXENT also significantly reduced the need for systemic corticosteroids or surgery and produced improvements in smell and chronic rhinosinusitis symptoms. In a subgroup of asthma patients, DUPIXENT improved lung function and asthma control.
No new safety signals were observed.
Detailed results will be submitted for presentation at future medical conferences and will support global regulatory filings.
The FDA approved DUPIXENT in March 2017 for eczema (atopic dermatitis).
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