- Regeneron Pharmaceuticals Inc REGN and Sanofi SA SNY announced results from a Phase 3 open-label extension trial of Dupixent (dupilumab) as maintenance therapy in asthma patients aged 6 to 11.
- The trial assessed Dupixent when added to other asthma medications for uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation.
- Also read: Regeneron-Sanofi’s Dupixent Hits Primary Goal In Esophagitis Patients Below 11 Years.
- Children treated with Dupixent in the extension trial experienced:
- Low rate of severe asthma attacks with an average of 0.118-0.124 events per year, compared to 2.16-2.56 events per year at baseline in the pivotal trial.
- Sustained improvement in lung function at 52 weeks of 9.43-12.6 percentage points from baseline in the pivotal trial.
- Children who switched from placebo in the pivotal trial to Dupixent in the extension trial demonstrated an improvement of 8.71 percentage points in lung function at two weeks.
- The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved respiratory indications.
- Price Action: SNY stock is down 0.27% at $39.97 during the premarket session on the last check Tuesday.