05 Jun Topical Jublia Approved for Fungal Nail Infections in Children
MedicalResearch.com Interview with:
Tracey Vlahovic DPM, FFPM, FCPS
Clinical Professor, Department of Podiatric Medicine
Stanley and Pearl Landau Faculty Fellow
Adjunct Professor, Department of Microbiology, Temple
University School of Medicine
On Behalf of Ortho Dermatologics
MedicalResearch.com: What is the background for this study?
Response: JUBLIA® was first approved in 2014 for people 18 years of age and older. However, more and more children are being diagnosed with onychomycosis, so the goal of the study was to determine the safety and efficacy of Jublia in this patient population.
MedicalResearch.com: What are the safety and efficacy findings of the Phase 4 study in the pediatric population?
Response: The efficacy assessments showed that by week 52, 65 percent of patients achieved mycologic cure with a 36.7 percent mycologic cure rate observed as early as week 12. A total of 40 percent of patients had complete cure by week 52, and half of patients achieved clinical efficacy by the study conclusion.
MedicalResearch.com: What should readers take away from your report?
Response: We’re pleased to share that expanded labeling for Jublia further demonstrates the safety and efficacy of this treatment option for pediatric patients. Jublia is a reliable, safe treatment option for parents who would prefer a topical agent to manage their children’s toenail condition.
Disclosures: I served as the principal investigator on this study.
FDA has approved a supplemental New Drug Application for JUBLIA® topical solution, 10%, a treatment for onychomycosis which extends the age range included in the product’s label to children six years of age and older.
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