LAVAL - Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for JUBLIA (efinaconazole) topical solution, 10%, a treatment for onychomycosis, a fungal infection of the toenails, which extends the age range included in the product's label to children six years of age and older.1
JUBLIA was first approved in June 2014 in patients 18 years and older.
'Onychomycosis is increasingly being seen in pediatrics - representing 15 percent of all nail dystrophies in children,'2 said Bill Humphries, president, 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.'
The safety, pharmacokinetics and efficacy of JUBLIA in patients ages six to 16 years old were evaluated in a multicenter, open-label, single-arm Phase 4 study that enrolled 62 patients with mild-to-severe onychomycosis. The primary objectives were to evaluate the safety of JUBLIA over the 52 weeks of the study in pediatric subjects with at least mild onychomycosis of the toenails, as well as the pharmacokinetics of JUBLIA at four weeks in pediatric subjects 12 to 16 years with moderate-to-severe onychomycosis of the toenails. Efficacy assessments included mycologic cure (fungus-free), complete cure (completely clear nails and fungus-free), and clinical efficacy (
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