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Dupixent (Dupilumab) & Indications for Use

    Basic Details
    Last Updated
    Friday, February 23, 2024
    Original Posting Date
    Health Outcome(s)
    indications for use
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In 2017, the FDA approved Dupixent (dupilumab), an interleukin-4 receptor alpha agonist. Dupixent is currently indicated for atopic dermatitis for patients aged six months and older, asthma for patients aged six years and older, chronic rhinosinusitis with nasal polyposis in adult patients, eosinophilic esophagitis in patients one year old and older, and prurigo nodularis in adult patients. FDA sought to understand whether Dupixent was being used off-label prior to the eosinophilic esophagitis approval, and if so, to what extent.

    An analysis was completed in Sentinel in 2021 to investigate utilization patterns of Dupixent by varying cohort inclusion requirements with broad and narrow definitions of eosinophilic esophagitis. Overall, findings suggested that very few patients used Dupixent to treat eosinophilic esophagitis. As this analysis was conducted for informational purposes only, FDA did not take regulatory action.