FDA Approves Atopic Dermatitis Drug

A new drug for atopic dermatitis got FDA approval.

The US Food and Drug Administration (FDA) has approved crisaborole (Eucrisa/Anacor) for use in treating atopic dermatitis.

The ointment, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known.

According to the FDA, the safety and efficacy of Eucrisa were established in two placebo-controlled trials with a total of 1,522 participants ranging in age from two years of age to 79 years of age, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment.

Serious side effects of Eucrisa include hypersensitivity reactions.

The FDA warns it should not be used in patients who have had a hypersensitivity reaction to Eucrisa’s active ingredient, crisaborole. The most common side effect of Eucrisa is application site pain, including burning or stinging.

The FDA issued a news release on the approval, headlined “FDA approves Eucrisa for eczema.”

Related Coverage:

New Ointment Effective in Eczema, Study Finds

Crisaborole Ointment May Be Better Tolerated than Other Topic Treatments

Crisaborole Ointment: A Novel, Nonsteroidal Atopic Dermatitis Treatment for Children and Adults