Botulinum toxin A (Hugel)

Pictured: Doctor injecting Botox into the forehead of a woman/iStock, macniak The FDA on Monday approved Hugel America’s neurotoxin injection letibotulinumtoxinA-wlbg, now to be marketed as Letybo, for the treatment of glabellar lines—frown lines that appear in between the eyebrows—in adults. With the FDA’s greenlight, Hugel will now “accelerate” the transition to approved medical use, the company noted in its announcement. Hugel expects to launch Letybo in aesthetic centers in the U.S. in the latter half of 2024. Hugel America President James Hartman in a statement called Letybo the “leading neurotoxin brand” in South Korea, which is one of the most dynamic and active aesthetics markets in the world. The company, Hartman said, is “thrilled” with the approval which will help Hugel become a “top aesthetics brand in the U.S.” The FDA’s approval of Letybo is backed by data from three Phase III trials, which together involved more than 1,200 participants across various sites in the U.S. and Europe. According to its label, Letybo was able to elicit significant treatment success across all three studies, defined as none or mild glabellar lines and an improvement of at least two points on the Glabellar Line Scale versus baseline. Letybo’s label also carries a boxed warning for the distant spread of its toxin effect to other body parts, which may occur within hours to weeks after administration. “Swallowing and breathing difficulties can be life threatening and there have been reports of death,” the label read. Monday’s approval represents a triumphant culmination of Letybo’s rough regulatory road. The pharma first filed its Biologics License Application in 2021 but was rejected by the FDA in March 2022, with the regulator asking for additional data including chemistry, manufacturing and controls. Hugel resubmitted its application in October 2022, which the FDA accepted the same month. However, the FDA again denied approval in 2023. Hugel made another resubmission in September 2023 following a review of its facility management as well as other supplementary work to address the FDA’s concerns. With Letybo entering the U.S. market, Hugel is poised to challenge AbbVie’s blockbuster neuromuscular blocker Botox (botulinum toxin), which made more than $2.9 billion in global net revenues in 2023. Another strong competitor is Revance Therapeutics, whose Daxxify (daxibotulinumtoxinA-lanm) was approved in September 2022 for moderate-to-severe frown lines. At the time, the biotech touted Daxxify as the “first and only peptide-formulated neuromodulator with long-lasting results.” In Daxxify’s Phase III development program, its efficacy had a median duration of six months, with some patients even seeing maintained results up to nine months. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

South Korea's market leading neurotoxin in aesthetics set to launch in the second half of 2024. NEWPORT BEACH, Calif., March 4, 2024 /PRNewswire/ -- Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetics industry, today announced it received United States (U.S.) Food and Drug Administration (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 with the goal of launching 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 for updates on product availability. IMPORTANT SAFETY INFORMATION for LETYBO®  (letibotulinumtoxinA-wlbg)  Injection LETYBO® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems after treatment with LETYBO®:  Problems swallowing, speaking, or breathing, due to weakening of associated muscles can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.  Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms that include loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.  Do not receive LETYBO® if you are allergic to any of the ingredients in LETYBO® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as MYOBLOC® (rimabotulinumtoxinB), BOTOX®/BOTOX® COSMETIC (onabotulinumtoxinA), DYSPORT® (abobotulinumtoxinA), XEOMIN® (incobotulinumtoxinA), JEUVEAU® (prabotulinumtoxinA-xvfs), or DAXXIFY® (daxibotulinumtoxinA-lanm); or have a skin infection at the planned injection site; or are a child.  LETYBO® dosing units are not the same as, or comparable to, any other botulinum toxin product. Tell your healthcare provider about all your medical conditions, including side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles, drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you have received any other botulinum toxin product in the last 4 months or any in the past, and exactly which product you received (such as MYOBLOC®, BOTOX®/BOTOX® Cosmetic, DYSPORT®, XEOMIN®, JEUVEAU® or DAXXIFY®). LETYBO® may cause serious side effects, including allergic reactions (such as itching, rash, hives, wheezing, trouble breathing, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get help right away if you experience a serious side effect. No serious side events of distant spread of toxin effect associated with dermatologic use of LETYBO® have been reported in clinical studies at the dose of 20 Units for glabellar lines. The most common side effect of LETYBO® was headache. These are not all the possible side effects of LETYBO®. For more information, see the full Prescribing Information including Boxed Warning, and refer to the Medication Guide or talk with your doctor. To report side effects associated with LETYBO®, please call 1-877-390-2906. You may also report side effects to the FDA at 1-800-FDA-1088 or visit . APPROVED USE LETYBO® is a prescription medicine that is injected into muscles and used in adults to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) About Hugel Aesthetics Hugel Aesthetics, headquartered in the US, is a division of Hugel Inc., a global leader in the aesthetics industry. The company has offices in Australia and Canada, with future operations planned for New Zealand. Hugel Aesthetics is dedicated to making aesthetics more attainable for all. For more information, visit: . Contact: Hugel Aesthetics @ [email protected] SOURCE Hugel