Valeant's Antifungal Agent Luzu Wins FDA Approval
11/15/2013
The FDA has approved Luzu® (luliconazole, Valeant) Cream, 1% 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. It is the first topical azole antifungal agent approved to treat tinea cruris and tinea corporis with a one-week, once-daily treatment regimen. All other approved treatments require two weeks of treatment. Interdigital tinea pedis is approved with a two-week, once-daily treatment.
The approval was based on positive results from three pivotal studies evaluating safety and efficacy of Luzu Cream, 1% in patients with either tinea pedia 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, which means that the skin showed no clinical involvement and no evidence of fungus. In the first study, 26 percent of subjects treated with Luzu® were completely cleared, compared to only two percent of subjects treated with vehicle. In the second study, 14 percent 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 percent of subjects treated with Luzu® were completely cleared, compared to only four percent of subjects treated with vehicle.
The most common adverse events were mild application site reactions, reported in less than one percent of patients for both Luzu® and vehicle.
The approval was based on positive results from three pivotal studies evaluating safety and efficacy of Luzu Cream, 1% in patients with either tinea pedia 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, which means that the skin showed no clinical involvement and no evidence of fungus. In the first study, 26 percent of subjects treated with Luzu® were completely cleared, compared to only two percent of subjects treated with vehicle. In the second study, 14 percent 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 percent of subjects treated with Luzu® were completely cleared, compared to only four percent of subjects treated with vehicle.
The most common adverse events were mild application site reactions, reported in less than one percent of patients for both Luzu® and vehicle.