FDA approves Pfizer's eczema ointment
By Reuters Staff
(Reuters) - The U.S. Food and Drug Administration has approved Pfizer Inc's Eucrisa (crisaborole) ointment to treat mild-to-moderate eczema in patients two years and older.
"Today's approval 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, the FDA said in a statement.
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, the FDA said.
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.(c) Copyright Thomson Reuters 2016. Click For Restrictions - http://about.reuters.com/fulllegal.asp