FDA approves Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adolescents

Sanofi

11 March 2019 - Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis.

The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis 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.

The FDA evaluated the Dupixent application under Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. Dupixent was also granted Breakthrough Therapy designation by the FDA for inadequately controlled moderate-to-severe atopic dermatitis in adolescents. 

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics