The US Food and Drug Administration approved the neurotoxin, Letybo (letibotulinumtoxinA-wlbg), to treat moderate-to-severe glabellar lines in adults, Hugel Inc. announced last week.
According to a press release, Hugel Inc. plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the second half of 2024.
“We are thrilled with the FDA’s approval of Letybo,” stated James Hartman, President, Hugel America. “This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the US. 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 FDA approval is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the US and Europe, Hugel Inc. said.
“The results from the clinical trials for letibotulinumtoxinA demonstrate efficacy, and a convincing safety profile in the treatment of glabellar lines,” Joely Kaufman, MD, said. “These comprehensive outcomes provide me—and will provide my fellow injectors—with a high level of confidence in offering Letybo to patients.”
Letybo is expected to be available throughout the US later this year.
