FDA Approves Hugel America’s Letybo to Treat Moderate-to-Severe Frown Lines in Adults

Image credit: Olivier Le Moal | stock.adobe.com

The FDA has approved Hugel America, Inc’s Letybo (letibotulinumtoxinA-wlbg) for the treatment of moderate-to-severe frown (glabellar) lines in adults. Currently, the company is attempting to accelerate the process of going from approval to launch, aiming for a full release in the second half of 2024. Reportedly, the approval was based on positive results stemming from multiple Phase III trials, which included more than 1,000 participants from the United States and Europe.¹

"We are thrilled with the FDA's approval of Letybo. This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the US," said James Hartman, president, Hugel America, in a press release. "As South Korea's leading neurotoxin brand, our quality facial injectables are trusted by millions and we cannot wait to help even more people achieve their aesthetic aspirations."

The approval comes after the FDA initial sent a Complete Response Letter (CRL) last year in response to the company Biologics License Application (BLA) filed in October 2022. Hugel then sent out an additional BLA at the end of August, reviewing management of its facility and supplementary work in-line from requests received from the FDA in its CRL.²

"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,” said an official for Hugel, in a September 2023 press release.

Hugel also received a CRL in March 2022, with the FDA citing the need for supplemental data. As a result, the company sent out supplemental documents and data based on the requests along with an additional application for approval. To enhance efforts, the company appointed Hartman as the president of its American branch, further aiming to make the treatment one of the top brands in the US market within the first three years of launch.³

"The results from the clinical trials for letibotulinumtoxinA demonstrate efficacy, and a convincing safety profile in the treatment of glabellar lines. These comprehensive outcomes provide me – and will provide my fellow injectors – with a high level of confidence in offering Letybo to patients,” said Joely Koffman, MD, regarding the approval.

Currently, Letybo is a top product in Korea’s botulinum toxin market, with entrances to markets including China, Europe, and Australia.²

References

1. Hugel Receives FDA Approval in the United States of Letybo (letibotulinumtoxinA-wlbg) for Injection for the Treatment of Glabellar Lines. PR Newswire. March 4, 2024. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/hugel-receives-fda-approval-in-the-united-states-of-letybo-letibotulinumtoxina-wlbg-for-injection-for-the-treatment-of-glabellar-lines-302078434.html

2. Hugel resubmits BLA for its botulinum toxin, Letybo to the U.S. FDA. PR Newswire. September 1, 2023. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/hugel-resubmits-bla-for-its-botulinum-toxin-letybo-to-the-us-fda-301915484.html

3. Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA. PR Newswire. October 7, 2022. Accessed March 4, 2024. https://www.prnewswire.com/news-releases/hugel-resubmits-bla-for-its-botulinum-toxin-botulax-to-the-us-fda-301643587.html