The Food and Drug Administration (FDA) has expanded the approval of Jublia® (efinaconazole; Bausch Health) topical solution to include treatment of onychomycosis of the toenail(s) in patients aged ≥6 years. Previously, Jublia was only approved for adults aged ≥18 years.
The approval was based on data from a multicenter, open-label, single-arm phase 4 study that evaluated the efficacy, safety and pharmacokinetics of Jublia in 62 patients aged 6 to 16 years with mild to severe onychomycosis of the toenails. The primary end point was safety over 52 weeks, as well as pharmacokinetic assessment at 4 weeks in patients aged 12 to 16 years with moderate to severe onychomycosis. Efficacy assessments included mycologic cure, complete cure (completely clear nails and fungus-free), and clinical efficacy (<10% toenail involvement).
At week 52, results showed that 65% of patients achieved mycologic cure with a 36.7% mycologic cure rate observed as early as week 12. Additionally, 40% of patients achieved complete cure and 50% achieved clinical efficacy by week 52.
Regarding safety, Jublia was well tolerated with the most common treatment-related adverse event being ingrown nails. The systemic exposure of Jublia in children was comparable to that seen in adults.
“Onychomycosis is increasingly being seen in pediatrics – representing 15 percent of all nail dystrophies in children,” said Bill Humphries, president, Ortho Dermatologics. “With nearly 6 years of real-world use since its initial approval to treat adults in 2014, Jublia has a demonstrated safety and efficacy profile, and we are pleased the FDA has recognized it as a valuable treatment option for children with toenail fungal infections.”
Jublia topical solution 10% is supplied in 4mL and 8mL bottles containing 100mg of efinaconazole with an integrated flow-through brush applicator. A prescription savings program is available for eligible patients.
For more information visit jubliarx.com.