A pivotal Phase III trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged six to 11 years with uncontrolled moderate-to-severe asthma.
In a broad type two inflammatory asthma patient population, defined as having elevated eosinophils (EOS) or elevated fractional exhaled nitric oxide (FeNO), the Sanofi (Euronext: SAN) and Regeneron (Nasdaq: REGN) drug added to standard of care significantly reduced asthma attacks and improved lung function, as early as two weeks after the first dose, compared to standard of care alone.
"Children with uncontrolled moderate-to-severe asthma often struggle to breathe, largely because of their impaired lung function, and this can have a serious impact on their quality of life"More than 90% of children in the trial had at least one concurrent type two inflammatory condition including atopic dermatitis and eosinophilic esophagitis. Safety results from the clinical trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with moderate-to-severe asthma.
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