Valeant Pharmaceuticals International has received Health Canada regulatory approval for Jublia (efinaconazole 10% solution), a topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). This is the first regulatory approval worldwide for Jublia.
"Jublia represents the first new topical onychomycosis treatment approved in more than a decade, and we are very excited to bring this new treatment option to patients in Canada," said J. Michael Pearson, chairman and CEO of Valeant. "An effective topical therapy like Jublia is a logical treatment option to avoid drug interactions and systemic side effects, and we believe it will position us well to address a growing unmet need."
"There is a pressing need for an effective topical therapy for mild to moderate onychomycosis, especially in individuals who cannot tolerate or are not candidates for an oral antifungal," said Aditya K. Gupta, MD, PhD, FAAD, FRCP, professor, department of medicine, University of Toronto, Canada. "The Phase III clinical trial data for Jublia show that it is an effective and safe topical antifungal therapy for mild to moderate onychomycosis."
The solution is applied daily to the nail and does not present concerns for systemic side effects such as drug-drug interactions or acute liver injury. The two positive pivotal studies that were the basis for approval were published last year in the Journal of the American Academy of Dermatology and included 1,655 subjects with onychomycosis.
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. The most commonly reported adverse events in treated patients were application site dermatitis and application site vesicles.