FDA Approves Eucrisa Ointment for Eczema

PDE-4 inhibitor is indicated for patients 2 years of age and older

The FDA has approved crisaborole ointment (Eucrisa, Anacor Pharmaceuticals) for the treatment of mild-to-moderate eczema (atopic dermatitis) in patients 2 years of age and older. 

Atopic dermatitis, a chronic inflammatory skin disease, is the most common of the many types of eczema. The condition typically begins in childhood and can last through adulthood. Atopic dermatitis is caused by a combination of genetic, immune, and environmental factors. In atopic dermatitis, the skin develops red, scaly, and crusted bumps that are extremely itchy. Scratching leads to swelling, cracking, “weeping” of clear fluid, and finally, coarsening and thickening of the skin.

Crisaborole, applied topically twice daily, is a phosphodiesterase-4 (PDE-4) inhibitor, although its mechanism of action in atopic dermatitis is not known.

The safety and efficacy of crisaborole were established in two placebo-controlled studies involving a total of 1,522 participants 2 to 79 years of age with mild-to-moderate atopic dermatitis. Overall, the subjects treated with crisaborole achieved a greater response with clear or almost clear skin after 28 days of treatment.

The most common adverse effect of crisaborole is application-site pain, including burning and stinging. Serious adverse effects include hypersensitivity reactions.

Source: FDA; December 14, 2016.