FDA approves Jublia for onychomycosis in children
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The FDA approved a supplemental new drug application for Jublia to extend the age range in the product’s label to include children 6 years and older, Ortho Dermatologics, Bausch Health Companies’ dermatology business, announced in a press release.
Jublia (efinaconazole topical solution 10%) is indicated for the treatment of onychomycosis and was first approved for individuals 18 years and older in June 2014.
“Onychomycosis is increasingly being seen in pediatrics — representing 15% of all nail dystrophies in children,” Bill Humphries, Ortho Dermatologics president, said in the release. “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.”
A multicenter, open-label, single-arm phase 4 study in 62 patients found Jublia was safe for patients between 6 and 16 years of age. By week 52, 65% of patients were fungus-free, while 40% had clear nails and were fungus-free, the release said.