FDA Approves Crisaborole Ointment for Eczema

The FDA today approved Anacor Pharmaceuticals’ crisaborole ointment (Eucrisa) for the treatment of mild to moderate eczema in patients 2 years and older.

The drug, a phosphodiesterase 4 (PDE-4) inhibitor, is specifically indicated for the twice-daily treatment of atopic dermatitis, a common type of eczema in which patients develop red, itchy, swollen, and cracked skin.

The agency based its decision on the results of 2 placebo-controlled studies in which the safety and efficacy of Eucrisa were evaluated in a total of 1522 participants aged 2 to 79 years. The researchers found that patients who were treated with the drug achieved a greater response with clear or almost clear skin after 28 days compared with those who received placebo.

“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” said Amy Egan, MD, deputy director of the FDA’s Office of Drug Evaluation, in a press release.

The most common adverse event associated with the use of Eucrisa was application site pain, including burning or stinging. The FDA acknowledged that some trial participants also experienced hypersensitivity reactions, and warned that Eucrisa should not be used in patients with a history of such reactions to the drug’s active ingredient, crisaborole.