US FDA grants Valeant approval for Jublia NDA

Canadian drugmaker Valeant Pharmaceuticals International’s (TSX: VRX) US subsidiary has received approval from the US Food and Drug Administration for its New Drug Application for Jublia (efinaconazole 10% topical solution), for the treatment of onychomycosis of the toenails.

Michael Pearson, chairman and chief executive, said: “We acquired Jublia through our purchase of Dow Pharmaceutical Sciences in 2008 and advanced Jublia from pre-IND stage through clinical Phases I, II and III. We are working quickly to get this important product launched in the USA and Canada in the third quarter of 2014. We anticipate favorable managed care coverage in the USA, similar to other branded antifungal agents, with peak sales of $300-$800 million in the USA alone and we are also working with other regulatory agencies around the world on further approvals.”

Onychomycosis is a common and destructive nail infection that is undertreated largely because of the limitations of available treatments. Over-the-counter or prescription topical treatments provide limited efficacy and are often administered in conjunction with frequent debridement, or the scraping, cutting or removal of the nail. Prescription oral treatments are limited by drug interactions and serious safety concerns.