Hugel Resubmits BLA for Its Botulinum Toxin, Letybo to the U.S. Fda
September 01, 2023 at 04:30 pm IST
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Hugel 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.
Hugel Inc is a Korea-based company mainly engaged in the manufacture of biopharmaceuticals. The Company's product portfolio consists of botulinum toxins which used for treatment of benign essential blepharospasm and temporary improvement of moderate to severe glabellar lines including 50 unit types, 100 unit types and 200unit types; hyaluronic acid (HA) fillers which used for temporary removal of facial wrinkles including the chaeum premium No.1, the chaeum premium No.2, the chaeum premium No.3m the chaeum premium No.4, the chaeum MID 20A, the chaeum DEEP 20A, the chaeum SUB-Q 20A and the chaeum VOLUS 20A; wellages, blue roses and other cosmetics. The Company sells its products in domestic and overseas markets.
HUGEL, INC. 
