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FDA Approves Eucrisa for Eczema

FDA news release; 2016 Dec 14

The FDA has approved Eucrisa (crisaborole) ointment (Pfizer, Inc.) to treat mild to moderate eczema (atopic dermatitis) in patients aged 2 years and older.

Indication: Eucrisa is indicated for topical treatment of mild to moderate atopic dermatitis in patients aged 2 years and older.

Dosage and administration: Eucrisa, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known.

Safety and efficacy: The safety and efficacy of Eucrisa were established in 2 placebo-controlled trials with a total of 1,522 participants ranging in age from 2 years to 79 years, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment.

Adverse reactions: 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.

Citation:

US Food and Drug Administration. FDA approves Eucrisa for eczema. FDA web site. December 14, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533371.htm. Accessed December 16, 2016.

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