Valeant’s onychomycosis treatment Jublia gets FDA approval

Onychomycosis is a common and destructive nail infection that is currently undertreated due to the limitations of available treatments.

At present, over-the-counter (OTC) 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.

The company said that prescription oral treatments are limited by drug interactions and serious safety concerns.

Valeant chairman and chief executive officer Michael Pearson said the company acquired Jublia through its 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 U.S. and Canada in the third quarter of 2014," Pearson said.

"We anticipate favorable managed care coverage in the U.S., similar to other branded antifungal agents, with peak sales of $300-$800 million in the U.S. alone and we are also working with other regulatory agencies around the world on further approvals.

"This is the fourth product, sourced from our acquisition of Dow Pharmaceutical Sciences, for which we have received FDA approval – the other three being 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya and Retin-A Micro (tretinoin) Gel microsphere 0.08%.

"We have also filed a new treatment for acne, Onexton, which has a PDUFA date of November 30, 2014. All these compounds came through our Dow acquisition, bringing with it the full set of R&D capabilities from preclinical through regulatory."

Kaken Pharmaceutical, the licensor and business partner for efinaconazole, has also agreed to supply Valeant with the finished dosage form of Jublia for the US market.

Jublia is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).