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Regeneron: Phase 3 Trial Shows Dupixent Significantly Reduces Severe Asthma Attacks In Children

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) announced Tuesday that a pivotal Phase 3 trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma.

In the trial, Dupixent added to standard of care significantly reduced asthma attacks or exacerbations and improved lung function as early as two weeks after the first dose, compared to standard of care alone.

The trial was conducted on a broad type 2 inflammatory asthma patient population, defined as having elevated eosinophils or EOS or elevated fractional exhaled nitric oxide or FeNO.

In the trial, more than 90% of children had at least one concurrent type 2 inflammatory condition including atopic dermatitis and eosinophilic esophagitis.

The companies noted that safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma.

George Yancopoulos, President and Chief Scientific Officer of Regeneron, said, "Even while taking maximum treatments including inhaled corticosteroids, they suffer from multiple asthma attacks each year that may require hospitalization. These impressive Phase 3 data in children with asthma show Dupixent significantly reduced annual severe asthma attacks and also improved lung function consistently across patients with markers of type 2 inflammation."

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