March 24, 2020

The U.S. FDA has approved an expanded indication for Eucrisa® (crisaborole) 2% ointment. The product, which was previously approved to treat mild-to-moderate atopic dermatitis (eczema) in patients as young as two years of age, can now be used in patients as young as three months old. Eucrisa is the first and only steroid-free, topical prescription medication FDA approved for use in this population.

Atopic dermatitis is relatively common in children, most often manifesting by five years of age. Chronic atopic dermatitis may occur in flares broken up by periods of remission that can last for years at a time. Symptoms include itchy dry skin, red and brownish gray patches of skin, small bumps that may leak fluid, rough and cracked skin, and raw and swollen skin. It can cause discomfort severe enough to interfere with daily activities and may lead to skin infections.

In a clinical trial that evaluated the use of Eucrisa in patients three months to two years of age, the product was well-tolerated and effective, with no new safety signals identified. Recommended dosing is a thin layer of ointment applied to the affected area of skin twice daily, regardless of the patient’s age.

Eucrisa first received FDA approval in 2016.

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