Dong-A ST said Wednesday that the Ministry of Food and Drug Safety (MFDS) has designated Jublia, its treatment for toenail fungus, as the reference listed drug (RLD).
RLD is an MFDS-approved drug product, the new generic versions of which have to show bioequivalence to receive approval from the ministry. A drug company seeking approval to market a generic equivalent must refer to the RLD in its approval process.
“Jublia is the only paste-form athlete's foot treatment approved in Korea that has excellent therapeutic effects and low adverse reaction,” the company said. “The therapy also showed similar treatment and full-recovery rate as orally taken conventional drugs.”
The drug also has excellent penetration to the existing medications, as its ingredient reaches the deep part of the nail quickly without any additional process, while superior antimicrobial power efficiently prevents bacterial growth, it said.
Canada and Korea recommend Jublia as first-line therapy for athlete's foot due to its low risk of adverse reactions.
In Canada, regulators recommend Jublia as the first-line treatment for mild and severe athlete’s foot with an infection area of less than 60 percent. In Korea, the Korean Society for Mycology has recommended the use of Jublia as a first-line treatment after taking the infected area and oral administration restraints into account.
“Jublia is a formula that overcomes the disadvantages of conventional oral antifungal agents, such as liver metabolism and drug interactions, but maintains its therapeutic effects,” said Lee Seong-woo, a staff at Dong-A ST’s marketing team. “This year we will do our best so that people with athlete's foot disease can experience better treatment.”
According to UBIST, the market research company, Jublia is the most sold athlete’s foot treatment in Korea with a 24 percent market share.