德克萨斯，沃思堡（2019年10月4日）GaldMA，一个专注于满足世界日益增长的皮肤健康需求的全球领导者，今天宣布，美国食品和药物管理局（FDA）批准阿克利夫（三叶虫素）乳膏，0.005%用于局部治疗痤疮。Aklief霜是唯一一种局部使用的视黄醇，它能选择性地靶向视黄酸受体（RAR）γ，这是在皮肤中发现的最常见的RAR。1，2，3三法罗汀是20多年来第一个获得美国FDA批准用于治疗痤疮的新视黄醇分子。4，5，6 Aklief面霜是第一个专门研究并证明可治疗面部（额头、脸颊、鼻子和下巴）和躯干（胸部、肩膀和背部）痤疮的局部治疗，为医疗专业人员和痤疮患者提供了另一种治疗选择。1

“尽管维甲酸是治疗痤疮的基础疗法，但几十年来几乎没有什么创新。”Sandra Johnson说，他是M.D.阿克利夫乳膏和史密斯堡约翰逊皮肤科皮肤科医生的临床试验的调查员。“在Aklief霜的批准下，我很高兴为我的病人提供一种独特的、高靶向性的维甲酸，它可以减少脸、背、胸和肩膀上的炎症性病变，这也被证明是安全和耐受性良好的。”

FDA批准阿克利夫乳膏是由两个关键的3期临床试验的数据支持的：每天一次的AKLIF乳膏治疗面部和躯干中度痤疮患者。1的两个相同的12周，随机，多中心，平行组，双盲，车辆控制的临床试验2，420例患者显示，Aklief乳膏与载体相比，最早在2周时，在面部、背部、肩部和胸部4周时，能显著减少炎症病变（P<0.05）。1例最常见的不良反应（发病率＞1%）包括应用部位刺激、应用部位瘙痒（瘙痒）和晒伤1。

“Aklief霜的批准强调了我们将新的活性分子带到社区的能力，甚至在成熟的治疗课程中也能创新。这是符合我们的意图改变的范式，甚至最常见和令人沮丧的皮肤病治疗，包括痤疮，说：“蒂波德门户博士，GalDrMA全球副总裁，处方。“我们很高兴将这一新的治疗方案添加到我们创新的、差异化的痤疮治疗组合中，它在面部和躯干痤疮方面的疗效已得到证实。”

Aklief霜预计将于2019年11月在美国上市。它将在45克泵中提供。GALDARMA正在与付款人、供应商和药房利益管理者紧密合作，以确保AccLIF霜广泛而快速的获得。该公司还将提供一个病人储蓄卡计划，GaldMaCARIONT**。

关于痤疮

痤疮是美国最常见的皮肤病，每年影响多达5000万美国人，约85%的年轻人。一种炎症性疾病，痤疮发生时，皮脂（油）和死皮肤细胞的组合堵塞毛孔，使细菌与痤疮（痤疮痤疮）生长。7，8痤疮的脸是最常见的，往往是最明显的表现疾病。超过一半的面部痤疮患者（52%）也有躯干痤疮。9成人痤疮往往比男性更易影响女性，成人发病的痤疮在20岁以上的女性中越来越普遍。10岁后痤疮，曾经被认为是男性的主要疾病，已被证明在女性中普遍存在。10种痤疮会引发抑郁、身体形象不佳和自尊心低下的感觉。

美国重要安全信息

适应症：Aklief（Trifarotene）面霜，0.005%是维甲酸，适用于9岁及以上的寻常痤疮患者的局部治疗。

不良事件：应用氟氯拉定乳膏治疗的患者中最常见的不良反应（发病率为1%）是应用部位刺激、应用部位瘙痒（瘙痒）和晒伤。

警告/预防措施：使用阿克利夫霜的患者可能会出现红斑、结垢、干燥和刺痛/灼烧。从治疗开始使用保湿霜，如果合适，根据这些不良反应的严重程度，减少使用Aklief霜的频率，暂停或停止使用。避免在伤口、擦伤或湿疹或晒伤皮肤上使用Aklief霜。使用阿克利夫霜治疗皮肤应避免使用“打蜡”作为脱毛方法。尽量减少阳光和日光灯的照射。当无法避免暴露时，在处理过的区域使用防晒霜和防护服。

德克萨斯，沃思堡（2019年10月4日）GaldMA，一个专注于满足世界日益增长的皮肤健康需求的全球领导者，今天宣布，美国食品和药物管理局（FDA）批准阿克利夫（三叶虫素）乳膏，0.005%用于局部治疗痤疮。Aklief霜是唯一一种局部使用的视黄醇，它能选择性地靶向视黄酸受体（RAR）γ，这是在皮肤中发现的最常见的RAR。1，2，3三法罗汀是20多年来第一个获得美国FDA批准用于治疗痤疮的新视黄醇分子。4，5，6 Aklief面霜是第一个专门研究并证明可治疗面部（额头、脸颊、鼻子和下巴）和躯干（胸部、肩膀和背部）痤疮的局部治疗，为医疗专业人员和痤疮患者提供了另一种治疗选择。1

“尽管维甲酸是治疗痤疮的基础疗法，但几十年来几乎没有什么创新。”Sandra Johnson说，他是M.D.阿克利夫乳膏和史密斯堡约翰逊皮肤科皮肤科医生的临床试验的调查员。“在Aklief霜的批准下，我很高兴为我的病人提供一种独特的、高靶向性的维甲酸，它可以减少脸、背、胸和肩膀上的炎症性病变，这也被证明是安全和耐受性良好的。”

FDA批准阿克利夫乳膏是由两个关键的3期临床试验的数据支持的：每天一次的AKLIF乳膏治疗面部和躯干中度痤疮患者。1的两个相同的12周，随机，多中心，平行组，双盲，车辆控制的临床试验2，420例患者显示，Aklief乳膏与载体相比，最早在2周时，在面部、背部、肩部和胸部4周时，能显著减少炎症病变（P<0.05）。1例最常见的不良反应（发病率＞1%）包括应用部位刺激、应用部位瘙痒（瘙痒）和晒伤1。

“Aklief霜的批准强调了我们将新的活性分子带到社区的能力，甚至在成熟的治疗课程中也能创新。这是符合我们的意图改变的范式，甚至最常见和令人沮丧的皮肤病治疗，包括痤疮，说：“蒂波德门户博士，GalDrMA全球副总裁，处方。“我们很高兴将这一新的治疗方案添加到我们创新的、差异化的痤疮治疗组合中，它在面部和躯干痤疮方面的疗效已得到证实。”

Aklief霜预计将于2019年11月在美国上市。它将在45克泵中提供。GALDARMA正在与付款人、供应商和药房利益管理者紧密合作，以确保AccLIF霜广泛而快速的获得。该公司还将提供一个病人储蓄卡计划，GaldMaCARIONT**。

关于痤疮

痤疮是美国最常见的皮肤病，每年影响多达5000万美国人，约85%的年轻人。一种炎症性疾病，痤疮发生时，皮脂（油）和死皮肤细胞的组合堵塞毛孔，使细菌与痤疮（痤疮痤疮）生长。7，8痤疮的脸是最常见的，往往是最明显的表现疾病。超过一半的面部痤疮患者（52%）也有躯干痤疮。9成人痤疮往往比男性更易影响女性，成人发病的痤疮在20岁以上的女性中越来越普遍。10岁后痤疮，曾经被认为是男性的主要疾病，已被证明在女性中普遍存在。10种痤疮会引发抑郁、身体形象不佳和自尊心低下的感觉。

美国重要安全信息

适应症：Aklief（Trifarotene）面霜，0.005%是维甲酸，适用于9岁及以上的寻常痤疮患者的局部治疗。

不良事件：应用氟氯拉定乳膏治疗的患者中最常见的不良反应（发病率为1%）是应用部位刺激、应用部位瘙痒（瘙痒）和晒伤。

警告/预防措施：使用阿克利夫霜的患者可能会出现红斑、结垢、干燥和刺痛/灼烧。从治疗开始使用保湿霜，如果合适，根据这些不良反应的严重程度，减少使用Aklief霜的频率，暂停或停止使用。避免在伤口、擦伤或湿疹或晒伤皮肤上使用Aklief霜。使用阿克利夫霜治疗皮肤应避免使用“打蜡”作为脱毛方法。尽量减少阳光和日光灯的照射。当无法避免暴露时，在处理过的区域使用防晒霜和防护服。

FDA Approves Aklief

FDA Approves Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne

FORT WORTH, Texas (October 4, 2019) Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved Aklief (trifarotene) Cream, 0.005% for the topical treatment of acne. Aklief Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.1,2,3 Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.4,5,6 Aklief Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and acne patients another treatment option.1

"While retinoids are foundational therapies to treat acne, there has been little innovation in decades.” said Sandra Johnson, M.D., FAAD, an investigator in the clinical trials of Aklief Cream and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas. “With the approval of Aklief Cream, I am excited to offer my patients a unique, highly targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders, that has also been shown to be safe and well-tolerated."

The FDA approval of Aklief Cream is supported by data from the two pivotal Phase 3 clinical trials of once-daily Aklief Cream in patients with moderate acne on the face and trunk.1 The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that Aklief Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05).1 Aklief Cream was well tolerated when used on the face, back, shoulders and chest.1 The most common adverse reactions (incidence >1%) included application site irritation, application site pruritus (itching) and sunburn.1 

“The approval of Aklief Cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” said Thibaud Portal PhD, Galderma Global Vice President, Prescription. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

Aklief Cream is expected to be available in the United States in November 2019. It will be provided in a 45 gram pump. Galderma is working closely with payers, providers and pharmacy benefit managers to ensure broad and rapid access to Aklief Cream. The company will also offer a patient savings card program, Galderma CareConnect*.

*Galderma CareConnect is only available for commercially insured or uninsured patients. Patients who are enrolled in a government-run or government-sponsored healthcare plan with a pharmacy benefit are not eligible to use the Galderma CareConnect Patient Savings Card.

About Acne

Acne is the most common skin disease in the United States, affecting up to 50 million Americans annually and approximately 85% of young people.  An inflammatory disease, acne occurs when a combination of sebum (oil) and dead skin cells clog pores, allowing the bacteria associated with acne (p. acnes) to grow.7,8 Acne on the face is the most common and often the most visible presentation of the disease. More than half of people with facial acne (52%) also have truncal acne. 9 Adult acne tends to affect women more often than men and adult-onset acne is becoming increasingly common in women in their 20s and beyond.10  Back acne, once thought to be a predominantly male disease, has been shown to be prevalent in females.10 Acne can trigger feelings of depression, poor body image and low self-esteem.11

Aklief Cream U.S. Important Safety Information

Indication: Aklief (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with Aklief Cream were application site irritation, application site pruritus (itching), and sunburn.
Warnings/Precautions: Patients using Aklief Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of Aklief Cream, suspend or discontinue use. Avoid application of Aklief Cream to cuts, abrasions or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with Aklief Cream. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Galderma

Galderma, the world’s largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions.  Galderma is a leader in the research and development of scientifically-defined and medically-proven solutions for the skin. Partnering with health care practitioners around the world to meet the skin health needs of people throughout their lifetime, the company aims to change the way the world thinks about skin health. For more information, please visit www.galderma.com.

Source: Galderma

Posted: October 2019