WASHINGTON -- The FDA said Wednesday that it has approved crisaborole (Eucrisa) as a treatment for eczema -- known technically as atopic dermatitis -- in patients ages 2 years and older.
The drug is a phosphodiesterase-4 inhibitor, applied topically twice daily.
Approval was based on two phase III trials, reported earlier this year at the American Academy of Dermatology annual meeting. Enrolling a total of 1,522 patients, the studies demonstrated that crisaborole treatment was better than placebo in achieving the primary endpoint, which was skin clearance or near clearance plus at least a two-point improvement in global assessment of disease severity after 4 weeks.
Just over 30% of patients receiving crisaborole achieved this endpoint, versus about 25% of the placebo groups, which was statistically significant.
When the two-point improvement was dropped from the endpoint, success rates rose to about 50% with crisaborole versus 30%-40% with placebo in the two trials.
Adverse events were generally mild and included burning or stinging at the application site, the FDA said.
Anacor Pharmaceuticals of Palo Alto, Calif., manufactures crisaborole.