ZYCLARA (imiquimod) 3.75% cream by Graceway Pharmaceuticals
The FDA has approved Zyclara (imiquimod cream, from Graceway Pharmaceuticals) for the treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults. This approval was based on results from Phase 3, double-blind, placebo-controlled clinical studies in 319 adults with 5–20 AK lesions in a large treatment area. The primary endpoint was complete clearance; the secondary endpoints were partial clearance rates and the percent change in AK number at the end of the study versus baseline. Data showed that Zyclara administered once-daily in two, two-week cycles was statistically superior to placebo. Patients treated with Zyclara had 36% complete clearance of AK versus 6% for placebo.