FDA: Dupixent Approved for the Treatment of Eczema
The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injection for the treatment of moderate-to-severe eczema in adults whose eczema is not adequately controlled by topical therapies or for whom topical therapies are not recommended.
Dupixent can be used with or without topical corticosteroids. Its active ingredient, dupilumab, inhibits inflammation by binding to the protein interleukin-4 receptor alpha subunit.
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Three placebo-controlled clinical trials were used to establish the safety and efficacy of Dupixent. The trials included 2119 adults with moderate-to-severe eczema not adequately controlled by topical medications. Overall, participants who were randomly assigned to receive Dupixent experienced clear or almost clear skin and reduction in itch after 16 weeks of treatment.
The most common adverse effects that were associated with Dupixent included injection site reactions, cold sores in the mouth or on the lips, and eye and eyelid inflammation. Dupixent may also cause serious allergic reactions and eye problems, including conjunctivitis and keratitis.
FDA approves new eczema drug Dupixent [press release]. FDA. March 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549078.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.