Valeant Pharmaceuticals Announces FDA Approval Of Jublia for Onychomycosis

The U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Valeant’s Jublia (efinaconazole 10% topical solution), the first topical triazole approved for the treatment of onychomycosis of the toenails.

Jublia is applied daily to the nail with a bottle that has a built-in flow-through brush applicator. It dries quickly and there is no need to remove excess product. The two positive pivotal studies—including 1,655 subject—that were the basis for approval were published last year in the Journal of the American Academy of Dermatology.

The studies’ primary endpoint was complete cure at Week 52, which required that the target nail show no clinical involvement and no evidence of fungus present by both KOH testing and a negative fungal culture. In Study 1, 17.8% of subjects treated with Jublia were completely cured, compared to only 3.3% of subjects treated with vehicle. In Study 2, 15.2% of subjects treated with Jublia were completely cured, compared to only 5.5% of subjects treated with vehicle.

Adverse events that were reported were generally mild and transient and were similar between subjects treated with Jublia and vehicle. The most commonly reported adverse events in patients treated with Jublia were application site dermatitis and application site vesicles.

"Onychomycosis is not only embarrassing and uncomfortable, but can lead to permanent nail damage and limited mobility in the general population," said American Podiatric Medical Association Executive Director and CEO Glenn B. Gastwirth, DPM. "We welcome the approval of Jublia and encourage people with onychomycosis of the toenails to discuss their condition with their podiatrist, or other healthcare professional to find a treatment that's right for them."

More in News