Letybo (letibotulinumtoxinA-wlbg) Receives FDA Approval

Hugel America, Inc., announced the achievement of a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for its neurotoxin, Letybo.

"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 of Hugel America, in a news 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."

This approval allows Letybo to be used in treating moderate-to-severe glabellar (frown) lines in adults. The company has plans to introduce Letybo to aesthetic clinicians in the latter half of 2024. Board-certified dermatologist Joely Kaufman, MD, lauded the efficacy and safety profile demonstrated by letibotulinumtoxinA in clinical trials

"The results from the clinical trials for letibotulinumtoxinA demonstrate efficacy, and a convincing safety profile in the treatment of glabellar lines," she said in a press release. "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 U.S. later this year. Injectors and consumers can visit www.hugel-aesthetics.com for updates on product availability.