FDA approves Eucrisa for eczema treatment
In a controlled trial, participants receiving Eucrisa achieved clear or almost clear skin after 28 days of treatment.
The FDA has approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema in patients aged 2 years and older.
Eucrisa is applied topically twice daily. Side effects include hypersensitivity reactions, and Eucrisa should not be used in patients who have had a hypersensitivity reaction to crisaborole. The most common side effect is application site pain, including burning or stinging.
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 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.
Atopic dermatitis is the most common of the many types of eczema and typically begins in childhood and lasts through adulthood. The cause of atopic dermatitis is a combination of genetic, immune, and environmental factors.
“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.
- US Food and Drug Administration. FDA approves Eucrisa for eczema [press released]. Published December 14, 2016. Accessed December 16, 2016.