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Ortho Dermatologics announces the U.S. FDA supplemental New Drug Application approval for efinaconazole 10% (JUBLIA) for the treatment of onychomycosis, a fungal toenail infection, in patients 6 years and older.
Ortho Dermatologics, a Bausch Health Companies Inc. dermatology business, announces the United States Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for efinaconazole 10% (JUBLIA, Ortho Dermatologics) for the treatment of onychomycosis, a fungal toenail infection.
Thanks to the newly approved sNDA, the drug can now be offered to patients as young as six years old. When efinaconazole was initially approved by the FDA in 2014, it could only be prescribed to individuals 18 years and older.
The age range expansion follows positive results from a phase 4, open-label, single-arm, 52-week, multicenter study conducted by Ortho Dermatologics that investigated the efficacy, safety and pharmacokinetics of efinaconazole 10% in 62 mild-to-severe onychomycosis patients ages six to 16 years old.
Results of efficacy assessments of efinaconazole 10% demonstrate 65% of patients achieved mycologic cure by week 52 with a 36.7% cure rate by week 12. Further, 40% of patients achieved complete cure by week 52 with half reaching clinical efficacy by the end of the study.
The drug was well tolerated by pediatric subjects and the systemic exposure data is comparable to previously reported data in adults. The most common treatment-related side effect observed in the study was ingrown toenails.
"Onychomycosis is increasingly being seen in pediatrics - representing 15% of all nail dystrophies in children," says Bill Humphries, president of Ortho Dermatologics. "With nearly six 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."
BioSpace. FDA Approves Ortho Dermatologics' Labeling For JUBLIA® (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old. BioSpace. https://www.biospace.com/article/releases/fda-approves-ortho-dermatologics-labeling-for-jublia-efinaconazole-topical-solution-10-percent-in-patients-as-young-as-six-years-old/. Published April 29, 2020. Accessed April 30, 2020.