Valeant Pharmaceuticals North America, a wholly-owned subsidiary of Valeant Pharmaceuticals International, has received a notice that the new drug application for Luzu (luliconazole) cream, 1% has been approved by the US Food and Drug Administration (FDA).
Luzu cream, 1% is indicated for the topical treatment of athlete's foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.
These are very common skin diseases caused predominantly by dermatophyte fungi.
Valeant Pharmaceuticals CEO and chairman J Michael Pearson noted the company is pleased to receive FDA approval for Luzu earlier than expected.
"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," Pearson added.
Luzu (luliconazole) 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. US approval is the first regulatory approval in North America. Luliconazole has been approved in Japan since 2005.
Luzu has been extensively studied in the US, 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 treatment duration of two weeks, the primary endpoint was stringently defined as complete clearance four-week post-treatment, which means that the skin showed no clinical involvement and no evidence of fungus.
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-week 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.