Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA) to update the label of Dupixent (dupilumab) to include efficacy and safety data for patients aged 12 and older with atopic dermatitis that involves uncontrolled moderate-to-severe hand or foot symptoms. The data from a late-stage trial indicate that the anti-IL-4/IL-13 biologic significantly improved outcomes, increasing the proportion of participants with clear or almost clear skin on hands and feet from 17% to 40% and raising the rate of participants experiencing a reduction in itch on hands and feet from 14% to 52% compared to placebo.
The safety profile of Dupixent in this patient population was found to be generally consistent with previous observations in atopic dermatitis trials. Dupixent is also approved for the treatment of other type 2 inflammation-related diseases, including asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic esophagitis (EoE), and prurigo nodularis.- Flcube.com
