FDA Approves Valeant's Jublia For Onychomycosis
By Cyndi Root
Valeant Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Jublia (efinaconazole 10% topical solution). The topical triazole is indicated for the treatment of onychomycosis of the toenails. Jublia was approved in Canada in October 2013. Valeant expects to begin marketing in the U.S. in the third quarter of 2014. Kaken Pharmaceutical is engaged to supply Jublia to the U.S. market.
Glenn B. Gastwirth, DPM, and the American Podiatric Medical Association Executive Director said, "Onychomycosis is not only embarrassing and uncomfortable, but can lead to permanent nail damage and limited mobility in the general population.” Michael Pearson, chairman and CEO of Valeant, 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.”
Jublia
Valeant acquired Jublia through its acquisition of Dow Pharmaceutical Sciences in 2008. It is the fourth product from Dow that has received FDA approval. Those drugs are 1% clindamycin and 5% benzoyl peroxide gel (IDP 111), Acanya, and Retin-A Micro (tretinoin) Gel microsphere 0.08%. Valeant took Jublia through its preclinical stages, clinical trials, and regulatory filings. Valeant has another Dow product, Onexton (an acne treatment), with a PDUFA date of November 30, 2014.
Jublia (efinaconazole 10% topical solution) is a topical agent for distal lateral subungual onychomycosis (DLSO). Patients apply the solution to the toenail via a bottle with a brush applicator. It dries quickly and no adverse effects have been reported such as liver injury or drug-drug interactions.
Jublia studies have been published in the Journal of the American Academy of Dermatology. Conducted with 1,655 patients, the studies were international in scope, including subjects in Canada. At week 52, investigators determined the primary endpoint was no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. Studies showed 15 to 18 percent cure rate in Jublia patients compared to the 3 to 5 percent cured when given a vehicle.
Onychomycosis
Onychomycosis is a nail infection. Prior to the approval of Jublia, treatments have been limited and the condition has been undertreated. Common treatments include debridement (scraping, cutting, or removal of the nail) or topical treatments. Drug interactions and safety concerns have limited oral treatments for the condition. About 35 million people in the U.S. have onychomycosis and 85 percent of them are untreated.