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Efinaconazole was first approved by the FDA in June 2014 for patients 18 and older.
The FDA has approved a supplemental New Drug Application (sNDA) for efinaconazole (Jublia, Bausch Health Companies) topical solution, 10% as a treatment for onychomycosis, a fungal infection of the toenails, in children aged 6 years and older. Efinaconazole was first approved by the FDA in June 2014 for patients 18 and older, according to Bausch Health.
The safety and efficacy of efinaconazole in patients aged 6 to 16 was evaluated in a single-arm phase 4 study of 62 patients with mild-to-severe onychomycosis. Over a course of 52 weeks, the safety of efinaconazole was evaluated in pediatric subjects with at least mild onychomycosis of the toenails, as well as the pharmacokinetics of efinaconazole at 4 weeks in pediatric subjects aged 12 to 16 years with moderate-to-severe onychomycosis of the toenails.
Assessments of efficacy in the study included mycologic cure, complete cure, and clinical efficacy. Efinaconazole was shown to be well-tolerated in the pediatric population, with the most common treatment-related side effect being ingrown nails. The efficacy assessments showed by week 52, with 65% of patients achieving mycologic cure, and 36.7% mycologic cure rate observed as early as week 12. In total, 40% of patients had complete cure by week 52, and half of patients achieved clinical efficacy by the study conclusion.
"Aside from being a cause of discolored toenails, onychomycosis may cause patients to experience nail discomfort in their shoes and during general activity. In certain populations, it can also potentially lead to a secondary infection," said Tracey Vlahovic, DPM, clinical professor, Department of Podiatric Medicine, and adjunct professor, Department of Microbiology, Temple University School of Medicine, in a press release. "The expanded labeling for Jublia further demonstrates the safety and efficacy of this treatment option, which I look forward to adding to my treatment regimen for pediatric patients."
FDA Approves Ortho Dermatologics' Labeling For JUBLIA® (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old [news release]. Laval, Quebec; Bausch Health: April 29, 2020.https://www.bauschhealth.com/news-room/news-releases/news-details/202004290700pr_news_uspr_____ny92338. Accessed April 29, 2020.