Canadian regulatory authority Health Canada has approved Valeant Pharmaceuticals International subsidiary Valeant Canada's new drug submission of Jublia for the treatment of onychomycosis.
Jublia is designated for the treatment of mild to moderate onychomycosis, a common and destructive nail infection caused by dermatophyte fungi.
Valeant Pharmaceuticals International chairman and chief executive officer Michael Pearson said Jublia represents the first new topical onychomycosis treatment approved in more than a decade.
"An effective topical therapy like Jublia is a logical treatment option to avoid drug interactions and systemic side effects, and we believe Jublia will position us well to address a growing unmet need," Pearson added.
University of Toronto, Canada professor of Department of Medicine Aditya Gupta said 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.
"The Phase III clinical trial data for Jublia show that it is an effective and safe topical antifungal therapy for mild to moderate onychomycosis," Gupta said.
"Jublia is likely to become widely prescribed by dermatologists, family physicians and other healthcare providers for the treatment of onychomycosis."
Jublia, which is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO), is applied daily to the nail with a novel bottle that has a built-in flow-through brush applicator.
