FDA Approves Crisaborole (Eucrisa) for Atopic Dermatitis

Troy Brown, RN

Disclosures

December 14, 2016

The US Food and Drug Administration (FDA) has approved crisaborole (Eucrisa, Pfizer Inc) for the treatment of mild to moderate atopic dermatitis (eczema) in patients aged 2 years and older.

"Today's approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis," Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor that is applied topically twice daily; its specific mechanism of action in atopic dermatitis is unknown.

The decision follows consideration of data from two placebo-controlled trials. The trials included a total of 1522 patients aged 2 to 79 years with mild to moderate atopic dermatitis. Patients who received crisaborole saw a greater response, with skin that was clear or almost clear after 28 days of treatment.

Serious adverse events include hypersensitivity reactions. The most frequent common adverse effect is pain at the site of application, including burning or stinging.

Crisabrorole is contraindicated in patients who have experienced hypersensitivity to crisaborole.

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