Letybo is a product in the Korean botulinum toxin market that has successfully entered global markets like China, Europe, and Australia, becoming the first Korean toxin brand to be introduced
Hugel has filed the BLA for the indication of glabellar lines. (Credit: Sam Moghadam Khamseh on Unsplash)
Medical aesthetics company Hugel has announced the resubmission of the biologics license application (BLA) to the US Food and Drug Administration (FDA) for its botulinum toxin, Letybo (letibotulinumtoxinA).
South Korea-based Hugel has filed the BLA for the indication of glabellar (frown) lines.
Letybo is a product in the Korean botulinum toxin market. It has successfully entered global markets like China, Europe, and Australia, becoming the first Korean toxin brand to be introduced.
Hugel submitted the BLA for Letybo in October 2022, and the US FDA sent Hugel a Complete Response Letter (CRL) earlier this year.
After reviewing the facility management and performing any additional work required by the CRL requirements made by the FDA, the company resubmitted the BLA.
Hugel also received Letybo’s permission in Canada in June of last year, and the company is now getting ready to market the product commercially this year.
A Hugel official commented: “The US is the world’s single largest botulinum toxin market and considered one of the big three global markets along with China and Europe, where Hugel operates.
“We remain committed to become a leading company in the global botulinum toxin industry through the successful launch of Letybo into the US market.”
Letybo is anticipated to receive marketing approval in the first quarter of 2024 because it typically takes six months from the time of a BLA filing to receive such approval.
In November 2022, Hugel secured marketing approval for 50 and 100 units of Letybo from the Therapeutic Goods Administration (TGA) of Australia.