U.S. License Holder:
Regeneron Pharmaceuticals
Date of License:
March-28-2017
Last Update:
Dec-15-2024
FDA-Approved Indications
DUPIXENT (dupilumab) is an interleukin-4 receptor alpha antagonist indicated:
Atopic Dermatitis: For the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent can be used with or without topical corticosteroids;
Asthma: As an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma;
Chronic Rhinosinusitis with Nasal Polyposis: As an add-on maintenance treatment in adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP);
Eosinophilic Esophagitis: For the treatment of adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE);
Prurigo Nodularis: For the treatment of adult patients with prurigo nodularis (PN);
Chronic Obstructive Pulmonary Disease: As an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.