Valeant Pharmaceuticals Luzu (luliconazole) Cream, 1% has been approved by the United States Food and Drug Administration (FDA) for the topical treatment of interdigital tinea pedis, tinea cruris and tinea corporis in patients 18 years of age and older.
Valeant notes that Luzu Cream, 1% is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a one-week, once-daily treatment regimen. (Interdigital tinea pedis is approved with a two-week, once-daily treatment.) The product has been approved in Japan since 2005.
Luzu has been extensively studied in the U.S., with three positive pivotal studies that were the basis for approval. These studies were conducted in 679 subjects with either tinea pedis or tinea cruris.
For the two pivotal studies in tinea pedis with a treatment duration of two weeks, the primary endpoint was stringently defined as complete clearance four-weeks post-treatment. In Study 1, 26% of subjects treated with Luzu were completely cleared, compared to only 2% of subjects treated with vehicle. In Study 2, 14% of subjects treated with Luzu were completely cleared, compared to only 3% of subjects treated with vehicle.
For the pivotal study in tinea cruris, complete clearance was assessed three weeks post-treatment. After one week of treatment, 21% of subjects treated with Luzu were completely cleared, compared to only 4% of subjects treated with vehicle. The most common adverse events were mild application site reactions, reported in less than one percent of subjects for both Luzu and vehicle.
"We are pleased to receive FDA approval for Luzu® earlier than expected," said J. Michael Pearson, chairman and CEO of Valeant. "This is the first safe and effective product indicated for daily use over a one-week period. This will be a welcome alternative to current options that require two weeks of treatment, and we believe Luzu will position us well to address this growing unmet need."