The U.S. Food and Drug Administration (FDA) has given its nod to Letybo (foletibotulinumtoxinA) for the treatment of moderate-to-severe glabellar lines in adults.
Now, there are six neuromodulators approved for cosmetic use in the U.S.: Botox Cosmetic (Allergan), Dysport (Galderma), Jeuveau (Evolus), Xeomin (Merz Aesthetic), Daxxify (Revance), and Letybo (Hugel).
Hugel plans to accelerate its transition for approved medical use with the goal of launching to aesthetic clinicians in the second half of 2024. Now the toxin is approved in 63 countries, including the US, China, and Europe.
“This is a huge achievement for Hugel as we focus on becoming a top aesthetics brand in the U.S.,” says James Hartman, President, 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.”
The FDA approval is backed by positive results from three completed phase III trials of more than 1,000 subjects in the U.S. and Europe.
Experts React
Coral Gables, FL-based dermatologist Joely Kaufman, MD, adds, “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.”
“Competition is good, and good science helps,” says TDD Editorial Advisory Board member Michael H. Gold, MD, the Medical Director of the Gold Skin Care Center. “I am excited to have another new toxin to use.”
Joel L. Cohen, MD, a dermatologist and the Director of AboutSkin Dermatology and DermSurgery in Greenwood Village and Lone Tree, CO, and a member of the TDD Editorial Advisory Board member, agrees. “In Korea, this is a top-selling neuromodulator brand that has demonstrated efficacy and popularity for patients over many years,” says Dr. Cohen who participated in the FDA trial which led to the twin’s approval. “It confirmed the efficacy and also safety of Letybo for the glabella, and now we recognize that Letybo will come to market soon, and likely eventually be part of a portfolio of facial injectables that will add to our cornucopia of products to choose from. ”
Hugel filed its first Biologics License Application in 2021, which was rejected by the FDA in 2022. The FDA sought additional data on chemistry and manufacturing, among other items at that time. Hugel resubmitted its application in October 2022 and was denied approval again in 2023. Hugel made another resubmission in September 2023 following a review of its facility management and other supplementary work to address the FDA’s concerns.
