FDA approves toenail fungus treatment in kids aged 6 years and older

The US Food and Drug Administration (FDA) has announced approval of a supplemental New Drug Application (sNDA) for Jublia (efinaconazole) topical solution, 10%, to treat onychomycosis, a fungal infection of the toenails, in children aged 6 years and older.¹ The drug had previously been approved for use in patients aged 18 years and older in 2014.

The safety and efficacy of the drug in patients aged 6 to 16 years was examined in a multicenter, open-label, single-arm Phase 4 study that enrolled 62 patients who had mild-to-severe onychomycosis. The study ran for 52 weeks.

The most common adverse effect of the drug was ingrown toenails. Systemic exposure of the drug in the pediatric patients was comparable to what had been seen in previous studies of adults. By week 52, 65% had achieved mycologic cure, with a 36.7% mycologic cure rate observed by week 12. Forty percent of participants had a complete cure by week 52 and half the sample achieved clinical efficacy by the end of the trial period.

Jublia is a product of Ortho Dermatologics (Bausch Health Companies, Laval, Quebec, Canada). The drug should cost $0 for the 4-mL and 8-mL sizes for eligible patients insured through most commercial health plans.

References:

1. FDA approves Ortho Dermatologics' labeling for Jublia (efinaconazole) topical solution, 10%, in patients as young as six years old [press release]. Cision PR Newswire. Published April 29, 2020. Accessed April 30, 2020. https://www.prnewswire.com/news-releases/fda-approves-ortho-dermatologics-labeling-for-jublia-efinaconazole-topical-solution-10-in-patients-as-young-as-six-years-old-301048996.html