Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, announced it received FDA approval on its neurotoxin, Letybo to treat moderate-to-severe glabellar (frown) lines in adults. In the coming months, Hugel plans to accelerate its transition for approved medical use to launch to aesthetic clinicians in the back half of 2024.
"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 U.S.," stated James Hartman, President, Hugel America. "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."
Joely Kaufman, MD, commented, "The results from the clinical trials for letibotulinumtoxinA demonstrate efficacy and a convincing safety profile in the treatment of glabellar lines1. These comprehensive outcomes provide me – and will provide my fellow injectors – with a high level of confidence in offering Letybo to patients."
FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the U.S. and Europe1. This botulinum toxin type A has been the leading neurotoxin brand in South Korea, one of the world's most dynamic aesthetic markets, for seven consecutive years. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canada, and Europe.
Letybo is expected to be available throughout the U.S. later this year. Injectors and consumers are encouraged to visit www.hugel-aesthetics.com for updates on product availability.
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