皮肤治疗产品提供商Merz Aesthetics首个用于同时治疗面部上部细纹的神经毒素XEOMIN获FDA批准-动脉网

Merz Aesthetics Announces FDA Approval of XEOMIN ® (incobotulinumtoxinA) as the First and Only U.S. Neurotoxin for the Simultaneous Treatment of Upper Facial Lines

businesswire 等信源发布 2024-07-24 16:00

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First approved in 2011, XEOMIN® was indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines. This new upper facial lines FDA approval adds the indication for the treatment of horizontal forehead lines and lateral canthal lines, or crow’s feet, in addition to the previous frown lines indication..

XEOMIN®于2011年首次获得批准，用于暂时改善中度至重度眉间线或皱眉线的外观。除了之前的皱眉线适应症外，FDA批准的这一新的面部上缘线还增加了用于治疗额头水平线和外can线或鱼尾纹的适应症。。

'XEOMIN® is the first and only FDA-approved neurotoxin for the simultaneous treatment of upper facial lines (forehead lines, frown lines and crow’s feet lines),” said Dr. Samantha Kerr, Chief Scientific Officer, Merz Aesthetics. “This new indication for XEOMIN® proves we are moving the needle within the toxin space and meeting the needs of our consumers as it comes to efficacy and results, while containing only the essential ingredients needed for treatment.”.

Merz美学首席科学官Samantha Kerr博士说：“XEOMIN®是FDA批准的第一种也是唯一一种同时治疗面部上纹（额头纹、皱眉纹和鱼尾纹）的神经毒素。”。“XEOMIN®的这一新适应症证明，我们正在毒素空间内移动针头，并在功效和结果方面满足消费者的需求，同时只包含治疗所需的必需成分。”。

XEOMIN® is now indicated for the temporary improvement in the appearance of moderate to severe upper facial lines. The total recommended XEOMIN® dose for treatment is 20 units for glabellar frown lines, 20 units for horizontal forehead lines and 24 units for the crow’s feet for a total of 64 units.

XEOMIN®现在用于暂时改善中度至重度上面部线条的外观。XEOMIN®治疗的总推荐剂量为眉间皱眉线20个单位，水平额头线20个单位，鱼尾纹24个单位，总共64个单位。

“Unlike other toxin treatments, we filter out all of the unnecessary ingredients in XEOMIN® using proprietary XTRACT Technology™, so we’re left with only the ingredients essential for treatment, which 90% of surveyed patients say they absolutely want in a neurotoxin treatment,” said Patrick Urban, President, North America, Merz Aesthetics.

“与其他毒素治疗不同，我们使用专有的Extract Technology™过滤掉XEOMIN®中所有不必要的成分，因此我们只剩下治疗所必需的成分，90%的受调查患者表示他们绝对希望接受神经毒素治疗，”Merz美学北美总裁Patrick Urban说。

“We’re so excited to hit this significant milestone for Merz Aesthetics as we continue to expand our ‘Beauty on Your Terms’ campaign and footprint within the aesthetics industry.”.

“我们很高兴能在Merz美学领域实现这一重要里程碑，因为我们将继续扩大“按您的条件进行美容”活动，并在美学行业占据一席之地。”。

In fact, unnecessary proteins found in some other toxin formulations may cause an immune response which can lead to a decreased effect and failure of treatment. In a recent survey, just over 1 in 3 toxin users reported to have experienced decreased, or lessening effects, of toxin treatments. The double filtration and removal of unnecessary proteins of XEOMIN®, also referred to as SmartTox, makes it less likely to lead to lessening or limiting results.

事实上，在其他一些毒素制剂中发现的不必要的蛋白质可能会引起免疫反应，从而导致效果下降和治疗失败。在最近的一项调查中，据报道，超过三分之一的毒素使用者经历了毒素治疗的减少或减轻效果。双重过滤和去除不必要的XEOMIN®蛋白质（也称为SmartTox），使其不太可能导致减少或限制结果。

The formulation minimizes the risk and offers a consistent experience across the new versatile indication..

该配方将风险降至最低，并在新的多功能适应症中提供一致的体验。。

The new indication comes on the coattails of the brand’s recent partnership with Demi Lovato and the continuation of the Merz Aesthetics multi-channel, digital-first ‘Beauty on Your Terms’ campaign. First launched in August 2022, the campaign was developed to introduce XEOMIN® to a younger, adult audience that is new to the injectables category and to empower them to embrace beauty on their own terms..

这一新迹象是在该品牌最近与黛米·洛瓦托（Demi Lovato）合作以及Merz美学多渠道、数字优先的“随心所欲的美丽”活动的延续下出现的。该活动于2022年8月首次启动，旨在向年轻的成年观众介绍XEOMIN®，这是注射类产品的新手，并使他们能够以自己的方式拥抱美丽。。

“In my opinion and experience, XEOMIN® is the smart choice for treatment of my upper facial lines,” said Demi Lovato, XEOMIN® brand partner. “The SmartTox formula is double filtered with only the ingredients essential for treatment to give me natural-looking results treatment after treatment.”

XEOMIN®品牌合作伙伴Demi Lovato表示：“根据我的观点和经验，XEOMIN®是治疗我上面部皱纹的明智选择。”。“SmartTox配方经过双重过滤，只含有治疗所必需的成分，让我在治疗后获得自然的效果。”

The approval for treatment of upper facial lines stems from clinical studies demonstrating the simultaneous treatment efficacy and safety of XEOMIN®. The phase three double-blind, placebo-controlled studies included 730 adult participants randomized to receive XEOMIN® or placebo. Both studies met their primary endpoints with XEOMIN® having a significantly higher response rate than placebo at Day 30 for all upper facial line areas.

批准治疗上面部线条源于临床研究，证明了XEOMIN®的同时治疗功效和安全性。三期双盲安慰剂对照研究包括730名随机接受XEOMIN®或安慰剂的成年参与者。这两项研究都达到了他们的主要终点，在第30天，XEOMIN®对所有面部上缘区域的反应率均明显高于安慰剂。

Results showed the simultaneous treatment of upper facial lines with XEOMIN® was well tolerated: all treatment-related adverse events were mild to moderate, and no treatment-related serious adverse events were observed. The unique formulation of XEOMIN® without unnecessary proteins had an excellent performance profile.

结果显示，XEOMIN®同时治疗上面部线条的耐受性良好：所有与治疗相关的不良事件均为轻度至中度，未观察到与治疗相关的严重不良事件。XEOMIN®的独特配方不含不必要的蛋白质，具有优异的性能。

Study data showed high patient satisfaction and continued efficacy over 14 months of multiple treatment cycles..

研究数据显示，在14个月的多个治疗周期中，患者满意度高，疗效持续。。

To learn more about XEOMIN® and locate a provider near you, visit XeominAesthetic.com where you can access the Find a Provider tool. You can also sign up for the Xperience+ Loyalty Program at xperiencemerz.com to receive instant and future rewards on XEOMIN® and additional Merz Aesthetics® treatments at your preferred practice..

要了解更多关于XEOMIN®的信息并找到您附近的提供商，请访问xeomineastic.com，在那里您可以访问“查找提供商”工具。您也可以在xperiencemerz.com上注册Xperience+忠诚度计划，在您的首选实践中获得XEOMIN®和其他Merz美学®治疗的即时和未来奖励。。

Follow @XeominAesthetic on Instagram to stay up to speed on the latest news.

关注Instagram上的@Xeomin美学，了解最新消息。

About Merz Aesthetics

关于梅尔茨美学

Merz Aesthetics is a medical aesthetics business with a long history of empowering health care professionals, patients and employees to live every day with confidence. We aim to help people around the world look, feel and live like the best versions of themselves — however they define it. Clinically proven, its product portfolio includes injectables, devices and skin care treatments designed to meet each patient’s needs with high standards of safety and efficacy.

Merz美学是一家医学美学企业，拥有悠久的历史，它赋予医疗保健专业人员、患者和员工每天充满信心的生活。我们的目标是帮助世界各地的人们看起来、感觉和生活都像他们自己的最佳版本-无论他们如何定义它。临床证明，其产品组合包括注射剂、设备和皮肤护理疗法，旨在以高标准的安全性和有效性满足每位患者的需求。

Being family owned for more than 110 years, Merz Aesthetics is known for building unique connections with customers who feel like family. Merz Aesthetics’ global headquarters is in Raleigh, N.C., USA, with a commercial presence in 52 countries worldwide. It is also a part of Merz Group, which was founded in 1908 and is based in Frankfurt, Germany.

梅尔茨美学家族拥有110多年的历史，以与感觉像家人的客户建立独特的联系而闻名。梅尔茨美学的全球总部位于美国北卡罗来纳州罗利，在全球52个国家拥有商业网点。它也是Merz Group的一部分，Merz Group成立于1908年，总部位于德国法兰克福。

Learn more at US.MerzAesthetics.com..

了解更多信息，请访问我们的网站。。

About XEOMIN® (incobotulinumtoxinA)

关于XEOMIN® （肉毒毒素A）

XEOMIN® (incobotulinumtoxinA) is a botulinum toxin type A and the first and only neurotoxin approved by the U.S. Food and Drug Administration (FDA) for the simultaneous treatment of upper facial lines – forehead lines, frown lines and crow’s feet. XEOMIN® is indicated for the temporary improvement in the appearance of moderate to severe upper facial lines.

XEOMIN®（incobotulinumtoxinA）是一种a型肉毒杆菌毒素，是美国食品和药物管理局（FDA）批准的第一种也是唯一一种神经毒素，可同时治疗面部上纹-额头纹，皱眉纹和鱼尾纹。XEOMIN®用于暂时改善中度至重度上面部线条的外观。

For more information, including Full Prescribing Information and Medication Guide, please visit www.xeominaesthetic.com. See below for Important Consumer Safety Information..

欲了解更多信息，包括完整的处方信息和药物指南，请访问www.xeomineastic.com。有关重要的消费者安全信息，请参阅下文。。

Head-to-head studies evaluating the relative risk of immunogenicity due to the presence or absence of complexing/unnecessary proteins have not been performed.

尚未进行评估由于存在或不存在复合/不必要蛋白质而导致的免疫原性相对风险的头对头研究。

XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

XEOMIN®（incobotulinumtoxinA）重要的消费者安全信息

Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive.

在开始服用XEOMIN（Zeo min）之前，请阅读药物指南，每次服用XEOMIN时，都可能会有新的信息。此处提供的风险信息不全面。

Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe upper facial lines (frown lines, forehead lines, and crow’s feet) in adults for a short period of time (temporary). Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com..

用途：XEOMIN是一种注射到肌肉中的处方药，用于在短时间内（暂时）改善成年人中度至重度面部上纹（皱眉纹、额头纹和鱼尾纹）的外观。请参阅下面的其他重要安全信息，以及Xeomin美学网站上的完整处方信息和药物指南。。

Warnings: XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:

警告：XEOMIN可能会导致严重的副作用，危及生命。如果您在使用XEOMIN治疗后的任何时间（数小时至数周）出现任何这些问题，请立即致电您的医生或寻求医疗帮助：

Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.

如果你用来呼吸和吞咽的肌肉变得虚弱，注射XEOMIN后数小时至数周内可能会出现吞咽，说话或呼吸问题。如果你在服用XEOMIN后出现严重的吞咽或呼吸问题，死亡可能会成为并发症。

People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.

患有某些呼吸问题的人可能需要使用颈部肌肉来帮助他们呼吸，并且XEOMIN可能会有更大的严重呼吸问题风险。

Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems..

吞咽问题可能会持续数月，在此期间，你可能需要一个喂食管来接收食物和水。如果吞咽问题严重，食物或液体可能会进入肺部。在服用XEOMIN之前已经有吞咽或呼吸问题的人患这些问题的风险最高。。

Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing..

毒素效应的传播。在某些情况下，肉毒杆菌毒素的作用可能会影响身体远离注射部位的区域，并引起称为肉毒中毒的严重症状。肉毒杆菌中毒的症状包括：全身力量和肌肉无力，复视，视力模糊和眼睑下垂，声音嘶哑或改变或丧失，说话不清，膀胱失控，呼吸困难，吞咽困难。。

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

这些症状可能在注射XEOMIN后数小时至数周内发生。这些问题可能会使你开车或从事其他危险活动变得不安全。

Do not use XEOMIN if you are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site..

如果您对XEOMIN或XEOMIN中的任何成分过敏（有关XEOMIN中的成分列表，请参阅本指南末尾），对任何其他肉毒杆菌毒素产品如rimabotulinumtoxinB（MYOBLOC®），onabotulinumtoxinA（BOTOX®，BOTOX®化妆品）或abotulinumtoxinA（DYSPORT®）有过敏反应，或在计划的注射部位有皮肤感染，请不要使用XEOMIN。。

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

在接受XEOMIN之前，告诉你的医生你的所有医疗状况，包括如果你：

have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)

患有影响肌肉和神经的疾病（例如肌萎缩侧索硬化症[ALS或Lou Gehrig病]，重症肌无力或Lambert-Eaton综合征）

have had any side effect from any other botulinum toxin in the past

过去有任何其他肉毒杆菌毒素的副作用

have a breathing problem such as asthma or emphysema

有呼吸问题，如哮喘或肺气肿

have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)

有吞咽问题或将食物或液体吸入肺部（误吸）的病史

have bleeding problems

有出血问题

have drooping eyelids

眼睑下垂

have plans to have surgery

计划做手术

have had surgery on your face

做过面部手术

are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.

怀孕或计划怀孕。尚不清楚XEOMIN是否会伤害您未出生的婴儿。

are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

正在母乳喂养或计划母乳喂养。目前尚不清楚XEOMIN是否会进入母乳。

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.

告诉你的医生你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。服用XEOMIN后，服用任何新药之前，请先咨询医生。

Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past. Especially tell your doctor if you

将XEOMIN与某些其他药物一起使用可能会导致严重的副作用。在你告诉医生你过去服用过XEOMIN之前，不要开始服用任何新药。特别是告诉你的医生如果你

have received any other botulinum toxin product in the last four months

在过去四个月内接受过任何其他肉毒杆菌毒素产品

have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received..

过去曾接受过肉毒杆菌毒素的注射，例如rimabotulinumtoxinB（MYOBLOC®），onabotulinumtoxinA（BOTOX®，BOTOX®化妆品）和abobotulinumtoxinA（DYSPORT®）。确保你的医生确切知道你服用了哪种产品。XEOMIN的剂量可能与您接受的其他肉毒杆菌毒素产品不同。。

have recently received an antibiotic by injection