批准日期：2018年8月23日

公司：正位皮肤科

治疗：痤疮

阿替诺（维甲酸）是一种治疗痤疮的局部维甲酸。

2018年8月24日，魁北克，拉瓦尔/prnewswire/--Ortho皮肤病学，世界上最大的处方皮肤病保健业务之一，Bausch Health Companys Inc.的一个部门（NYSE/TSX:BHC）。今天宣布，美国食品和药物管理局（fda）批准了altreno（维甲酸0.05%）洗剂的新药申请，该洗剂适用于9岁及以上的寻常痤疮患者的局部治疗。AtReNeO是维甲酸在洗剂中的第一种剂型，已被证明是有效的，一般耐受性良好。预计1的AlTreNo可在2018的第四季度获得。

“今天的FDA批准的AltReNo建立在我们强大的痤疮组合，为医生和患者提供一个信任的维甲酸在乳液配方，以提高用户的经验，包括保湿属性的透明质酸，甘油和胶原蛋白，”Bill Humphries说，总裁，Ortho Dermatologics。Altreno乳液很容易扩散，很快被皮肤吸收，让痤疮患者很容易将这种每天一次的治疗方法融入到他们的皮肤护理方案中。”

大量的临床资料表明，维甲酸是治疗痤疮的有效药物，被认为是局部治疗的基石。然而，一个常见的使用障碍是使用维甲酸治疗与皮肤刺激有关，如干燥和脱皮，以及敏感性。在临床试验中，Altreno洗剂提供了维甲酸（一种维甲酸）的有效性，该维甲酸是一种普遍耐受性良好的制剂，在不到4%的患者中出现皮肤干燥、疼痛、肿胀、刺激和脱皮。

“外用维甲酸对所有痤疮患者都是基础治疗，但它们往往会引起皮肤刺激，”纽约西奈山医院皮肤科美容和临床研究主任Joshua Zeichner博士说。鉴于维甲酸预期的疗效，加上已证实的耐受性，Altreno将是我的许多患者的理想选择。”

Altreno临床资料

在两个相同的多中心、随机、双盲、车辆控制的第3阶段研究中，共对1640名患者进行altreno评价，以确定其安全性和有效性。数据显示，与载体相比，奥替诺洗剂在炎症和非炎症性病变方面均显著减少。在这些研究中接受治疗的患者中，试验1和试验2中接受altreno治疗的患者的炎症病变的平均绝对减少量分别为13.1和13.9，而接受vehicle治疗的患者的平均绝对减少量分别为10.6和10.7。此外，试验1和试验2中，接受Altreno治疗的患者的非炎性病变的平均绝对值分别为17.8和21.9，而接受Vehicle治疗的患者的平均绝对值分别为10.6和13.9。同样，在试验1和试验2的第12周，分别有16.5%和19.8%的患者用维甲酸0.05%洗剂治疗成功（通过评估整体严重性评分和“清楚”或“几乎清楚”）总体严重性至少有2级改善，而用载体治疗的患者只有6.9%和12.5%。

最常见的不良反应发生在1%以上的受试者和大于载具的是干燥，疼痛红斑，刺激和脱落。当无法避免阳光照射时，应涂防晒霜和穿防护服。如果对鱼过敏是因为可能对鱼蛋白过敏，请小心使用Altreno。

临床试验数据还显示，到第12周，使用奥替诺洗剂的患者满意度（根据第12周完成的1396项患者满意度调查评估）显著高于使用奥替诺洗剂的患者满意度，使用奥替诺洗剂的患者满意度比使用载体的患者满意度高出53%（p<0.001）。十分之九的病人报告说他们对他们的治疗感到满意。治疗组患者的平均痤疮生活质量评估值较治疗前有统计学意义的增加；从基线检查到治疗12周，Altreno组患者的平均得分分别为7.4（自我感知，与治疗前相比为6.7，P=0.003）、6.8（角色情感，与治疗前相比为6.0，P=0.003）、4.8（角色社交，与治疗前相比为4.6，p=0.038）和6.5（痤疮症状，与5.6相比，p<0.001）。

批准日期：2018年8月23日

公司：正位皮肤科

治疗：痤疮

阿替诺（维甲酸）是一种治疗痤疮的局部维甲酸。

2018年8月24日，魁北克，拉瓦尔/prnewswire/--Ortho皮肤病学，世界上最大的处方皮肤病保健业务之一，Bausch Health Companys Inc.的一个部门（NYSE/TSX:BHC）。今天宣布，美国食品和药物管理局（fda）批准了altreno（维甲酸0.05%）洗剂的新药申请，该洗剂适用于9岁及以上的寻常痤疮患者的局部治疗。AtReNeO是维甲酸在洗剂中的第一种剂型，已被证明是有效的，一般耐受性良好。预计1的AlTreNo可在2018的第四季度获得。

“今天的FDA批准的AltReNo建立在我们强大的痤疮组合，为医生和患者提供一个信任的维甲酸在乳液配方，以提高用户的经验，包括保湿属性的透明质酸，甘油和胶原蛋白，”Bill Humphries说，总裁，Ortho Dermatologics。Altreno乳液很容易扩散，很快被皮肤吸收，让痤疮患者很容易将这种每天一次的治疗方法融入到他们的皮肤护理方案中。”

大量的临床资料表明，维甲酸是治疗痤疮的有效药物，被认为是局部治疗的基石。然而，一个常见的使用障碍是使用维甲酸治疗与皮肤刺激有关，如干燥和脱皮，以及敏感性。在临床试验中，Altreno洗剂提供了维甲酸（一种维甲酸）的有效性，该维甲酸是一种普遍耐受性良好的制剂，在不到4%的患者中出现皮肤干燥、疼痛、肿胀、刺激和脱皮。

“外用维甲酸对所有痤疮患者都是基础治疗，但它们往往会引起皮肤刺激，”纽约西奈山医院皮肤科美容和临床研究主任Joshua Zeichner博士说。鉴于维甲酸预期的疗效，加上已证实的耐受性，Altreno将是我的许多患者的理想选择。”

Altreno临床资料

在两个相同的多中心、随机、双盲、车辆控制的第3阶段研究中，共对1640名患者进行altreno评价，以确定其安全性和有效性。数据显示，与载体相比，奥替诺洗剂在炎症和非炎症性病变方面均显著减少。在这些研究中接受治疗的患者中，试验1和试验2中接受altreno治疗的患者的炎症病变的平均绝对减少量分别为13.1和13.9，而接受vehicle治疗的患者的平均绝对减少量分别为10.6和10.7。此外，试验1和试验2中，接受Altreno治疗的患者的非炎性病变的平均绝对值分别为17.8和21.9，而接受Vehicle治疗的患者的平均绝对值分别为10.6和13.9。同样，在试验1和试验2的第12周，分别有16.5%和19.8%的患者用维甲酸0.05%洗剂治疗成功（通过评估整体严重性评分和“清楚”或“几乎清楚”）总体严重性至少有2级改善，而用载体治疗的患者只有6.9%和12.5%。

最常见的不良反应发生在1%以上的受试者和大于载具的是干燥，疼痛红斑，刺激和脱落。当无法避免阳光照射时，应涂防晒霜和穿防护服。如果对鱼过敏是因为可能对鱼蛋白过敏，请小心使用Altreno。

临床试验数据还显示，到第12周，使用奥替诺洗剂的患者满意度（根据第12周完成的1396项患者满意度调查评估）显著高于使用奥替诺洗剂的患者满意度，使用奥替诺洗剂的患者满意度比使用载体的患者满意度高出53%（p<0.001）。十分之九的病人报告说他们对他们的治疗感到满意。治疗组患者的平均痤疮生活质量评估值较治疗前有统计学意义的增加；从基线检查到治疗12周，Altreno组患者的平均得分分别为7.4（自我感知，与治疗前相比为6.7，P=0.003）、6.8（角色情感，与治疗前相比为6.0，P=0.003）、4.8（角色社交，与治疗前相比为4.6，p=0.038）和6.5（痤疮症状，与5.6相比，p<0.001）。

Altreno (tretinoin) Lotion

Date of Approval: August 23, 2018
Company: Ortho Dermatologics
Treatment for: Acne

Altreno (tretinoin) is a topical retinoid for the treatment of acne.

LAVAL, Quebec, Aug. 24, 2018 /PRNewswire/ -- Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc. (NYSE/TSX: BHC), today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Altreno is the first formulation of tretinoin in a lotion, and has been shown to be effective and generally well-tolerated.1 Altreno is expected to be available during the fourth quarter of 2018.

"Today's FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user's experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen," said Bill Humphries, president, Ortho Dermatologics. "Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen."

Extensive clinical data has shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness and peeling, and sensitivity. In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients.1,2

"Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation," said Joshua Zeichner, M.D., director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City. "With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients."

Altreno Clinical Data

Altreno was evaluated in two identical multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies, totaling 1,640 patients to determine its safety and efficacy. The data demonstrated that Altreno lotion resulted in statistically significant reductions in both inflammatory and non-inflammatory lesions compared to vehicle. In the population of patients treated in these studies, patients treated with Altreno saw a mean absolute reduction of 13.1 and 13.9 in inflammatory lesions in trials 1 and 2, respectively, compared to 10.6 and 10.7 in patients treated with vehicle. In addition, those treated with Altreno saw a mean absolute reduction of and 17.8 and 21.9 in non-inflammatory lesions in trials 1 and 2, compared to 10.6 and 13.9 in patients treated with vehicle. Also at Week 12, 16.5% and 19.8% of patients in trials 1 and 2, respectively, achieved treatment success (at least a 2-grade improvement in global severity by Evaluator Global Severity Scores and 'clear' or 'almost clear') with tretinoin 0.05% lotion, compared to only 6.9% and 12.5% with vehicle.1

The most common adverse reactions occurring in >1% of subjects and greater than vehicle were dryness, pain erythema, irritation and exfoliation. Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. Use Altreno with caution if allergic to fish due to potential for allergenicity to fish protein.

The clinical trial data also showed patient satisfaction (as assessed by 1,396 patient satisfaction surveys completed at Week 12) was significantly greater with Altreno lotion by Week 12, with patient satisfaction of those treated with Altreno lotion increased by 53% compared to 43% with vehicle (P<0.001). Nine out of 10 patients reported that they were satisfied with their treatment. Patients in the treatment group saw a statistically significant increase in mean Acne-QoL assessments compared to vehicle; increase in mean scores from baseline to Week 12 with Altreno were 7.4 (self-perception, versus 6.7 for vehicle, P=0.003), 6.8 (role-emotional, versus 6.0, P=0.003), 4.8 (role-social, versus 4.6, P=0.038) and 6.5 (acne symptoms, versus 5.6, P<0.001).2

About Acne Vulgaris

Acne is a skin condition that occurs when hair follicles become plugged with oil and skin cells, often causing whiteheads, blackheads or pimples and appearing on the face, forehead, chest, upper back and shoulders. Acne is most common among people ages 12 to 24, though it can affect people of all ages. Depending on its severity, acne can cause emotional distress and scar the skin.3

Acne is the most common skin problem in the United States. Up to 50 million Americans have acne.4