The U.S. Food and Drug Administration on December 14, 2016 approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. According to the National Eczema Association 31.6 million American have eczema, and at least 17.8 million have moderate to severe eczema or atopic dermatitis.
Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as "eczema," which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema and onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, "weeping" clear fluid, and finally, coarsening and thickening of the skin.
Eucrisa provides another treatment option for patients dealing with mild to moderate atopic dermatitis," said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).
Eucrisa, 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 Pfizer, “EUCRISA is the first and only non-steroidal topical monotherapy that inhibits the PDE-4 enzyme in the skin. Overactive PDE-4 has been shown to contribute to the signs and symptoms of AD”.
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. Eucrisa 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.
Eucrisa is manufactured by Pfizer.
FDA Press Release
Pfizer Press Release