Dupixent Receives Expanded Indication
March 12, 2019 – The U.S. FDA has approved an expanded indication for Dupixent® (dupilumab), manufactured by Regeneron, to treat patients as young as 12 years of age who have moderate-to-severe atopic dermatitis (eczema) and whose disease is not adequately controlled with topical prescription therapies or for whom those therapies are not advisable. Previously, the product was approved to treat adults with the condition.
A chronic inflammatory condition, eczema can lead to severe itching and skin irritation, as well as a number of other symptoms including cracked or oozing skin. The condition typically manifests in childhood and can persist into adulthood. Flare-ups occur periodically, and can be separated by years at a time. Eczema may also be associated with asthma, other allergies, poor sleep, and skin infections.
Dupixent’s recommended dosing for adolescents is based on body weight. An initial dose of 400mg is given by subcutaneous injection for children who weigh less than 60kg (132 pounds), with subsequent injections of 200mg administered once every other week. For children who weigh 60kg or more, the initial dose is 600mg, and subsequent dosing is 300mg given every other week.
Originally approved in 2017, Dupixent is also indicated as an add-on maintenance treatment for patients at least 12 years of age who have moderate-to-severe eosinophilic asthma or who have oral corticosteroid dependent asthma.