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 the U.S. Food and Drug Administration (FDA) accepted the company’s Supplemental New Drug Application (sNDA) 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，美国食品和药物管理局（FDA）接受该公司针对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。

The Prescription Drug User Fee Act ('PDUFA') action date assigned by the Agency is in Q4 2024..

该机构指定的《处方药用户费用法案》（“PDUFA”）行动日期为2024年第4季度。。

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，作为一种每日一次，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 being studied in the ADORING Phase 3 development program and included in the sNDA submission for AD..

与ADORING第三阶段开发计划中研究的强度和配方相同，并包含在sNDA提交的AD中。。

Atopic dermatitis, commonly referred to as eczema, is one of the most common inflammatory skin diseases that causes inflammation, intense itch, redness, and irritation of skin and impacts approximately 16.5 million adults and more than 9.6 million children in the U.S. Approximately 80% of individuals affected by atopic dermatitis experience disease onset prior to 6 years of age; if approved VTAMA cream may be available for children as young as 2 years old affected with atopic dermatitis..

特应性皮炎，通常称为湿疹，是最常见的炎症性皮肤病之一，可引起炎症，强烈瘙痒，发红和皮肤刺激，影响美国约1650万成年人和960多万儿童。约80%受特应性皮炎影响的个体在6岁之前发病；如果获得批准，VTAMA乳膏可用于2岁以下患有特应性皮炎的儿童。。

“The FDA acceptance of our sNDA is an important milestone in our efforts to bring VTAMA cream, as a potentially safe and well-tolerated non-steroidal treatment option, to adults and children as young as 2 years old who suffer from atopic dermatitis,” said Todd Zavodnick, Chief Executive Officer of Dermavant.

Dermavant首席执行官托德·扎沃德尼克（ToddZavodnick）说：“FDA接受我们的sNDA是我们努力将VTAMA乳膏作为一种潜在安全且耐受性良好的非甾体治疗选择带给患有特应性皮炎的成年人和2岁以下儿童的一个重要里程碑。”。

“Our commitment to patients is unwavering, and we remain highly focused on preparing for the commercial launch of VTAMA cream, subject to FDA approval, for its second indication of atopic dermatitis.”.

“我们对患者的承诺是坚定不移的，我们仍然高度专注于准备VTAMA乳膏的商业上市，该乳膏须经FDA批准，用于第二种特应性皮炎的适应症。”。

The regulatory application 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 an open-label maximal usage pharmacokinetics (MUPK) trial in children aged 2-17 years, and the interim analysis results of ADORING 3, a Phase 3, 48-week, open-label, extension trial..

监管应用得到了ADORING 1和ADORING 2的阳性3期数据的支持，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2-17岁儿童的开放标签最大使用药代动力学（MUPK）试验，以及ADORING 3的中期分析结果，这是一项为期48周的开放标签扩展试验。。

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 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，不含类固醇的外用乳膏，被批准用于成人轻度，中度和重度斑块状牛皮癣-没有标签安全警告或注意事项，也没有使用时间或体表面积的限制。。

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, extension trial.

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周的开放标签延长试验。

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最常见于儿童，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银屑病。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。