Hugel, a medical aesthetics company, announced that the company resubmitted the BLA for its botulinum toxin, Letybo (letibotulinumtoxinA) on August 31st (local time), for the indication of glabellar (frown) lines to the U.S. FDA.
Hugel had received a Complete Response Letter (CRL) from the U.S. FDA earlier this year after submitting the BLA for Letybo in October 2022. The company has resubmitted the BLA after completing a review of the facility management and supplementary work in-line with the CRL requests received from the FDA.
As it takes around six months to obtain marketing approval from the period of a BLA submission, marketing approval for Letybo is projected for the first quarter of 2024.
Letybo is the No.1 product in the Korean botulinum toxin market and has successfully entered global markets such as China, Europe, and Australia, becoming the first Korean toxin brand to be launched. Hugel also received approval for Letybo in Canada in June of last year and is preparing for commercial launch within the year.
A Hugel official said, "The U.S. 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 U.S. market."
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