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 www.hugel-aesthetics.com for updates on product availability.

IMPORTANT SAFETY INFORMATION

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 www.fda.gov/medwatch.

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: www.hugel-aesthetics.com.

SOURCE Hugel

Posted: March 2024