Valeant Pharmaceuticals International, Inc. announced today that its wholly owned subsidiary, Valeant Canada LP, has received notice that the New Drug Submission for Jublia® has been approved from the Canadian regulatory authority, Health Canada. Jublia® (efinaconazole 10% topical solution) is indicated for the treatment of mild to moderate onychomycosis,
a common and destructive nail infection caused predominantly by dermatophyte fungi. The only currently approved topical treatments are lacquers with limited efficacy. Oral treatments are limited by drug interactions and numerous safety concerns including the potential for acute liver injury. Laser treatments only improve the appearance of the nail. “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 chief executive officer. “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.” “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,” stated Dr. Aditya K. Gupta, M.D., Ph.D., F.A.A.D., F.R.C.P(C), 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. Jublia® is likely to become widely prescribed by dermatologists, family physicians and other healthcare providers for the treatment of onychomycosis”
