Hugel Makes a Comeback: Resubmission of Letybo Botulinum Toxin BLA to the U.S. FDA

Hugel’s Grand Comeback: Letybo Botulinum Toxin Aims for FDA Approval in Q1 2024

SEOUL, South Korea, Sept. 1, 2023 /PRNewswire/ — Hugel, the global leader in medical aesthetics, has made a resounding announcement. On August 31st (local time), the company resubmitted its Biologics License Application (BLA) for Letybo (letibotulinumtoxinA) to the U.S. FDA, targeting the treatment of glabellar (frown) lines.

This move comes on the heels of a previous setback when Hugel received a Complete Response Letter (CRL) from the U.S. FDA earlier in the year, following its initial BLA submission in October 2022. Undeterred, Hugel embarked on a comprehensive overhaul of facility management and supplementary efforts, aligning with the FDA’s requests outlined in the CRL.

With the typical timeline for marketing approval spanning around six months from BLA submission, Hugel anticipates securing approval for Letybo in the first quarter of 2024.

Letybo, already a standout product in the Korean botulinum toxin market, has made its mark on the global stage, conquering markets in China, Europe, and Australia as the first Korean toxin brand to do so. Notably, Hugel secured approval for Letybo in Canada in June of the previous year and is gearing up for a commercial launch within the year.

A Hugel spokesperson emphasized, “The U.S. stands as the world’s largest botulinum toxin market, alongside China and Europe, where Hugel has established a significant presence. Our commitment remains unwavering as we strive to lead the global botulinum toxin industry with the triumphant introduction of Letybo to the U.S. market.

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