FDA approves Jublia for Onychomycosis - Valeant Pharma

The FDA has approved the New Drug Application (NDA) for Jublia (efinaconazole 10% topical solution), from Valeant Pharmaceuticals, the first topical triazole approved for the treatment of Onychomycosis of the toenails. The two pivotal studies that were the basis for approval were published last year in the Journal of the American Academy of Dermatology and were conducted in 1,655 subjects.

For the pivotal studies, the primary endpoint was complete cure at Week 52, which required that the target nail show no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with Jublia were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with Jublia were completely cured, compared to only 5.5% of subjects treated with vehicle. Adverse events that were reported were generally mild and transient and were similar between subjects treated with Jublia and vehicle.