of South Korea The market leading aesthetic neurotoxin is set to launch in the second half of 2024.
NEWPORT BEACH, CA., March 4, 2024 /PRNewswire/ — Hugel America, Inc., a division of Hugel Inc., a global leader in the medical aesthetic industry, announced today that it has received United States (US) Food and Drug Administration (FDA) approval of its neurotoxin, Letybo for the treatment of moderate to severe membranous lines in adults. In the coming months, Hugel plans to accelerate its transition to approved medical use with the goal of marketing to aesthetic clinicians in the second half of 2024.
“We are thrilled with the FDA approval of Letybo. This is a huge achievement for Hugel as we focus on becoming a leading beauty brand in the US,” said James Hartman, President, Hugel America. “As South Korea’s leading neurotoxin brand, our quality facial injectables are trusted by millions and we look forward to helping even more people achieve their aesthetic aspirations.”
Jolly KaufmanMD, commented, “Clinical trial results for letibotulinotoxin A demonstrate efficacy and a convincing safety profile in the treatment of mucosal lines1. These comprehensive results give me – and will give my fellow injectors – a high level of confidence in offering Letybo to patients.”
FDA approval is supported by positive results from three completed phase III trials involving more than 1,000 people in the US and Europe1. This botulinum toxin type A was the leading brand of neurotoxin South Korea, one of the most dynamic beauty markets in the world, for seven consecutive years. Hugel has sold over 26 million vials in 50+ different countries including Australia, Canadaand Europe.
Letybo is expected to be available across the US later this year. Injectors and consumers are encouraged to visit www.hugel-aesthetics.com for product availability updates.
IMPORTANT SAFETY INFORMATION about LETYBO® (letibotulinumtoxinA-wlbg) Injection
LETYBO® can 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 the weakening of the muscles involved it can be severe and lead to loss of life. You are at the highest risk if these problems pre-exist before the injection. Swallowing problems can last for several months.
- Spread of toxin effects. The effect of botulinum toxin can affect areas away from the injection site and cause serious symptoms including loss of strength and general muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, difficulty speaking words clearly , loss of bladder control, difficulty breathing and difficulty swallowing.
Do not take 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), JEUVEDAYvxum® ® (daxibotulinumtoxinA-lanm); or have a skin infection at the planned injection site. or is a child.
LETYBO® dosage units are not the same 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 eyes. breathing, swallowing, bleeding or heart problems. plans to have surgery. weakness of the muscles of the forehead, drooping of the eyelids. you had surgery on your face you are pregnant or breast-feeding or planning to become pregnant or breast-feeding.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements.
Especially tell your healthcare provider if you do you have received any other botulinum toxin product in the past 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® can cause serious side effects, including allergic reactions (such as itching, rash, hives, wheezing, difficulty breathing or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, decreased blinking and corneal problems). Tell your healthcare provider or get help right away if you experience a serious side effect. There are no serious far-reaching side effects of the toxin associated with the dermatological use of LETYBO® have been reported in clinical studies at the dose of 20 units for striae lines. Its most common side effect LETYBO® it was a headache.
These are not all its possible side effects LETYBO®. For more information, see the full Prescribing Information including boxed warning and refer to Medication Guide or talk to your doctor. To report adverse reactions related to LETYBO®, call 1-877-390-2906. You can also report adverse reactions to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
AUTHORIZED USE
LETYBO® is a prescription medicine that is injected into a muscle and is used in adults to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (ink lines)
About Hugel Aesthetics
US-based Hugel Aesthetics is a division of Hugel Inc., a global leader in the aesthetics industry. The company has offices in Australia and Canadawith future work planned New Zealand.
Hugel Aesthetics is dedicated to making aesthetics more attainable for everyone. For more information, visit: www.hugel-aesthetics.com.
Contact:
Hugel Aesthetics @ [email protected]
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1 Letybo USA Package Insert |
SOURCE Hugel
