FDA approves Eucrisa for atopic dermatitis

The FDA announced it has approved Eucrisa ointment to treat mild-to-moderate atopic dermatitis 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, stated in a press release.

Eucrisa (crisaborole; Pfizer) is a phosphodiesterase 4 inhibitor, which is to be applied twice daily, although its specific mechanism in atopic dermatitis is unknown, according to the release.

Results of two placebo-controlled trials with 1,522 participants aged 2 to 79 years with mild-to-moderate atopic dermatitis established the safety and efficacy of crisaborole. Patients who received crisaborole achieved clear or almost clear skin after 28 days of treatment, according to the release.

Hypersensitivity reactions were serious side effects of crisaborole, and the ointment should not be used in patients who have had hypersensitivity reaction to crisaborole. Application site pain, including burning and stinging, were the most common adverse events, according to the release.

Reference: www.fda.gov