Eucrisa Ointment Approved by Food and Drug Administration to Treat Eczema

Eucrisa Ointment Approved by Food and Drug Administration to Treat Eczema

Approval gives eczema patients another option for treatment

December 15, 2016

The Food and Drug Administration (FDA) has approved Eucrisa ointment for the treatment of mild to moderate eczema in patients two years old and older.

Eczema, or atopic dermatitis, is a chronic inflammatory skin disease. Of the many types of eczema, atopic dermatitis is the most common, and its onset usually starts in childhood, potentially lasting through adulthood. A combination of genetic, immune, and environmental factors is the cause. The skin of those with this disease develops red, scaly, crusted bumps that are extremely itchy. When they are scratched, it leads to the skin swelling, cracking, "weeping" clear fluid, and eventually coarsening and thickening.

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

Eucrisa's safety and effectiveness were established in two placebo-controlled trials that included 1,522 participants whose ages ranged from two to 79, all of whom had mild to moderate atopic dermatitis. Overall, those who used Eucrisa experienced a greater response of clear or almost-clear skin after 28 days of treatment.

There are serious side effects of Eucrisa, including hypersensitivity reactions. Patients who have experienced a hypersensitivity reaction to crisaborole, the active ingredient in Eucrisa, should not use it. The most common side effect is pain at the site of application, including burning or stinging.