- Bausch Health’s (TSX:BHC) topical fungal toenail treatment has received US FDA approval for use on children as young as six
- Named Jublia, the topical solution contains efinaconazole, a drug used to treat onychomycosis, a common fungal infection in the toenail
- The company’s dermatology business, Ortho Dermatologics, gained the approval from the US Food and Drug Administration
- The product has been on the market since 2014, but was only available to people over the age of 18
- Bausch Health Companies (BHC) is up 4.61 per cent, with shares trading for C$25.62 at 11:51am EST.
Bausch Health’s (TSX:BHC) topical fungal toenail treatment has received US FDA approval for use on children as young as six.
The US Food and Drug Administration granted the approval to the company’s dermatology business, Ortho Dermatologics.
The treatment, named Jublia, is a topical solution containing efinaconazole, a drug used to treat Onychomycosis.
Onychomycosis is a common type fungal infection in the toenail. The condition most commonly causes toenail discolouration but can lead to pain and even cause the nail to detach.
The product has been on the market since 2014, but was only available to adults over the age of 18.
The approval follows a Phase Four trial of the drug in children aged six to sixteen. The study followed 62 participants over 52 weeks to monitor the effects of the solution on younger patients.
The study found that by week 52, 65 per cent of the patients had seen a significant reduction in fungus. 40 per cent of the patients were completely free of the infection.
Bill Humphries, President of Ortho Dermatologics, believes the approval will help many children suffering from the condition.
“Onychomycosis is increasingly being seen in pediatrics – representing 15 percent of all nail dystrophies in children,”
“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. We are pleased the FDA has recognised it as a valuable treatment option for children with toenail fungal infections,” he said.
Bausch Health Companies (BHC) is up 4.61 per cent, with shares trading for C$25.62 at 11:51am EST.
