LONG BEACH, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Dermavant Sciences, a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for VTAMA® (tapinarof) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older..

加利福尼亚州长滩和瑞士巴塞尔——（商业新闻短讯）——Dermavant Sciences是一家致力于开发和商业化免疫皮肤病创新疗法的生物制药公司，今天宣布，它已经向美国食品和药物管理局（FDA）提交了VTAMA®（tapinarof）乳膏的补充新药申请（sNDA），1%用于成人和2岁及以上儿童特应性皮炎（AD）的局部治疗。。

VTAMA cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant, and steroid-free, topical cream for both acute treatment and long-term management of AD. VTAMA cream, 1% is currently approved for the topical treatment of plaque psoriasis in adults in the U.S.

VTAMA乳膏是一种新型的芳烃受体激动剂，正在开发中，是一种每日一次，美容优雅，无类固醇的局部乳膏，用于AD的急性治疗和长期管理。VTAMA乳膏目前被批准用于美国成年人斑块状银屑病的局部治疗。

and is the same strength and formulation studied in the ADORING Phase 3 development program and included in the sNDA submission for atopic dermatitis..

并且与ADORING Phase 3开发计划中研究的强度和配方相同，并包含在sNDA提交的特应性皮炎中。。

Atopic dermatitis, commonly referred to as eczema, is one of the most common inflammatory skin diseases, impacting approximately 16.5 million adults and more than 9.6 million children in the U.S. Over 85% of people with AD experience itching every day, making it the most common and burdensome symptom.

特应性皮炎，通常称为湿疹，是最常见的炎症性皮肤病之一，影响美国约1650万成年人和960多万儿童。超过85%的AD患者每天都会瘙痒，这是最常见和最沉重的症状。

More than 67% of patients with AD report that itch interfered with their sleep in the past week and more than 50% of children with AD report that sleep disturbance is one of the most bothersome symptoms of AD..

超过67%的AD患者报告说瘙痒在过去一周干扰了他们的睡眠，超过50%的AD儿童报告说睡眠障碍是AD最令人烦恼的症状之一。。

“The prevalence of atopic dermatitis, an extremely burdensome skin condition, continues to grow, and there is an increasing need for new, long-term, treatment options, especially for children,” said Todd Zavodnick, Chief Executive Officer of Dermavant. “Today’s submission of our sNDA marks a significant milestone as we work towards the approval of VTAMA cream for patients suffering from atopic dermatitis, as well as the families and caregivers of these patients.

Dermavant首席执行官托德·扎沃德尼克（ToddZavodnick）表示：“特应性皮炎（一种极其沉重的皮肤病）的患病率持续上升，人们越来越需要新的长期治疗方案，尤其是儿童。”。“今天我们提交的sNDA标志着一个重要的里程碑，因为我们正在努力批准VTAMA乳膏用于特应性皮炎患者以及这些患者的家属和护理人员。

We are confident, that VTAMA cream, if approved by the FDA, will be well positioned as a safe, well-tolerated, steroid-free topical treatment option for patients 2 years of age and older with AD and could provide for long-term disease management, representing meaningful advancement for patients, caregivers, and healthcare providers.”.

我们相信，如果FDA批准，VTAMA乳膏将成为2岁及以上AD患者安全，耐受性良好，无类固醇的局部治疗选择，并可提供长期疾病管理，代表患者，护理人员和医疗保健提供者的有意义的进步。”。

Today’s sNDA submission is supported by positive Phase 3 data from ADORING 1 and ADORING 2, two identical, double-blind, randomized, vehicle-controlled, pivotal trials, as well as data from an interim analysis of ADORING 3, a Phase 3, 48-week, open-label, long-term extension study. In the pivotal trials, VTAMA cream demonstrated highly statistically significant improvement compared to vehicle (both P<0.0001) in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) scores of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline at Week 8, the primary endpoint.

今天的sNDA提交得到了来自ADORING 1和ADORING 2的积极的第三阶段数据的支持，这是两项相同的，双盲的，随机的，媒介物对照的关键试验，以及来自ADORING 3的中期分析的数据，这是一项为期48周的开放标签长期扩展研究。在关键试验中，VTAMA乳膏在经过验证的研究者特应性皮炎全球评估（vIGA AD）评分为0（清晰）或1（几乎清晰）时，与媒介物相比，表现出高度统计学显着的改善（均P＜0.0001），在第8周（主要终点）时，与基线相比至少有2级改善。

VTAMA cream also demonstrated highly statistically significant improvement in the proportion of patients with ≥75% improvement in the Eczema Area and Severity Index (EASI75) from baseline to Week 8 compared to patients on vehicle (both P<0.0001), a key secondary endpoint in the pivotal trials. Patients 12 years of age and older, the population in whom the PP-NRS is validated, who received VTAMA cream also experienced a statistically significant improvement in itch as assessed by a ≥4-point improvement in the patient reported Peak Pruritus Numeric Rating Scale (PP-NRS) score compared to patients on vehicle (P=0.0366 for ADORING 1 and P=0.0015 for ADORING 2), another key secondary endpoint.

VTAMA乳膏从基线到第8周，湿疹面积和严重程度指数（EASI75）改善≥75%的患者比例与车辆患者相比也有高度统计学意义的改善（均P＜0.0001），这是关键试验的次要终点。接受VTAMA乳膏治疗的12岁及以上患者（PP-NRS经过验证的人群）的瘙痒程度也有统计学上的显着改善，这是通过患者报告的瘙痒峰值数字评分量表（PP-NRS）评分与车辆上的患者相比有≥4分的改善来评估的（崇拜1的P=0.0366，崇拜2的P=0.0015），另一个关键的次要终点。

VTAMA cream, 1% data indicated no new safety or tolerability signals of concern in this population including children 2 years of age and older. Adverse events were mostly mild to moderate with a low study discontinuation rate due to adverse events..

VTAMA乳膏，1%的数据表明该人群（包括2岁及以上的儿童）没有新的安全性或耐受性信号。不良事件大多为轻度至中度，由于不良事件导致的研究中断率较低。。

On May 24, 2022, Dermavant announced the FDA approved VTAMA® (tapinarof) cream, 1% for the treatment of plaque psoriasis in adults. The approval made VTAMA cream the first non-steroidal topical novel chemical entity launched for psoriasis in the U.S. in more than 25 years. VTAMA cream is a once- daily, cosmetically elegant, steroid-free, topical cream approved for mild, moderate, and severe plaque psoriasis in adults – with no label safety warnings or precautions, or restrictions on duration of use or body surface area..

2022年5月24日，Dermavant宣布推出FDA批准的VTAMA®（tapinarof）乳膏，1%用于治疗成人斑块状银屑病。该批准使VTAMA乳膏成为25年多来美国首家针对牛皮癣推出的非甾体外用新型化学实体。VTAMA乳膏是一种每日一次，美容优雅，无类固醇的局部乳膏，批准用于成人轻度，中度和重度斑块状牛皮癣-没有标签安全警告或预防措施，也没有使用时间或体表面积的限制。。

IMPORTANT SAFETY INFORMATION

重要安全信息

Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu)..

适应症：VTAMA®（tapinarof）乳膏，1%是一种芳烃受体激动剂，用于局部治疗成人斑块状银屑病。不良事件：用VTAMA乳膏治疗的受试者中最常见的不良反应（发生率≥1%）是毛囊炎（毛孔周围红肿），鼻咽炎（鼻子和喉咙疼痛或肿胀），接触性皮炎（皮疹或刺激，包括瘙痒和发红，脱皮，灼热或刺痛），头痛，瘙痒（瘙痒）和流感（流感）。。

You are encouraged to report negative side effects of prescription drugs to the FDA.

鼓励您向FDA报告处方药的负面副作用。

Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

See full Prescribing Information and Patient Information.

请参阅完整的处方信息和患者信息。

About Dermavant’s Phase 3 Program for VTAMA cream in Atopic Dermatitis

关于Dermavant针对特应性皮炎的VTAMA乳膏的第三阶段计划

ADORING is Dermavant’s Phase 3 atopic dermatitis (AD) clinical development program for VTAMA® (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), a 48-week open-label, long-term extension study.

ADORING是Dermavant针对VTAMA®（tapinarof）乳膏的3期特应性皮炎（AD）临床开发计划，占1%，其中包括ADORING 1（NCT05014568）和ADORING 2（NCT05032859），以及ADORING 3（NCT05142774），这是一项为期48周的开放标签长期扩展研究。

About Atopic Dermatitis

关于特应性皮炎

Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affects over 26 million people in the U.S. alone and up to 10% of adults worldwide. AD occurs most frequently in children, affecting up to 20% worldwide. The disease results in itchy, red, swollen, and cracked skin, often affecting the folds of the arms, back of the knees, hands, face, and neck.

特应性皮炎（AD），通常称为湿疹，是最常见的炎症性皮肤病之一，仅在美国就有2600多万人受到影响，全世界成年人中就有10%受到影响。AD最常发生在儿童中，影响全球高达20%。这种疾病会导致皮肤发痒、发红、肿胀和破裂，通常会影响手臂的褶皱、膝盖的背部、手、脸和脖子。

Itching is an especially bothersome symptom in AD, and tends to worsen at night, disturbing sleep and causing fatigue, which in children can lead to inattention at school. People with AD may also experience social and emotional distress due to the visibility and discomfort of the disease..

在AD中，瘙痒是一种特别令人烦恼的症状，并且在夜间会恶化，扰乱睡眠并引起疲劳，这可能导致儿童在学校注意力不集中。AD患者也可能由于疾病的可见度和不适而经历社交和情绪困扰。。

About Dermavant

关于Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development.

Dermavant Sciences是Roivant Sciences的子公司，是一家生物制药公司，致力于开发和商业化免疫皮肤病学的创新疗法。Dermavant的重点是开发有潜力解决高度未满足的医疗需求的疗法，同时提高研究和临床开发的效率。

The company’s medical dermatology pipeline includes earlier-development, late-stage and commercialized product candidates that target specific unmet needs in two of the largest growing immuno-dermatology markets, plaque psoriasis and atopic dermatitis, as well as other immunological and inflammatory diseases.

该公司的医疗皮肤病学渠道包括早期开发，晚期和商业化的候选产品，这些产品针对两个增长最大的免疫皮肤病市场，斑块状牛皮癣和特应性皮炎以及其他免疫和炎症疾病的特定未满足需求。

Dermavant is marketing VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. The FDA approved VTAMA cream for the topical treatment of mild, moderate, and severe plaque psoriasis in May 2022. Dermavant has been developing VTAMA cream for the treatment of atopic dermatitis in adults and children 2 years of age and older and released positive topline results from its ADORING 1 and 2 pivotal Phase 3 clinical trials in 1H 2023.

Dermavant正在销售1%的VTAMA®（tapinarof）乳膏，用于局部治疗成人斑块状牛皮癣。2022年5月，FDA批准VTAMA乳膏用于局部治疗轻度，中度和重度斑块状牛皮癣。Dermavant一直在开发VTAMA乳膏，用于治疗成人和2岁及以上儿童的特应性皮炎，并于2023年上半年发布了其备受推崇的1期和2期关键3期临床试验的阳性结果。

Dermavant’s pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential treatment option for immunological and inflammatory diseases with multiple potential routes of administration..

Dermavant的管道包括DMVT-506，这是一种正在开发的下一代芳烃受体（AhR）激动剂，可作为多种潜在给药途径的免疫和炎症性疾病的潜在治疗选择。。

For more information, please visit www.dermavant.com and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

有关更多信息，请访问www.dermavant.com，并在Twitter（@dermavant）和LinkedIn（dermavant Sciences）上关注我们。

©2024 Dermavant Sciences, Inc. All Rights Reserved. Dermavant and VTAMA are the registered trademarks of Dermavant Sciences, GmbH. vIGA-AD is the trademark of Eli Lilly and Co.

©2024 Dermavant Sciences，Inc.保留所有权利。Dermavant和VTAMA是Dermavant Sciences，GmbH的注册商标。vIGA AD是礼来公司的商标。