- 46.4% of subjects receiving VTAMA cream, 1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 18.0% on vehicle (P<0.0001)
- All secondary endpoints were met with a high degree of statistical significance, including 59.1% of subjects treated with VTAMA cream who achieved the key secondary endpoint of EASI75 (P<0.0001)
- Meaningful impact on the key secondary endpoint of pruritus (itch) was demonstrated with 52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieving a ≥4-point reduction in the PP-NRS at Week 8 (P=0.0015)
- Rollover rate of 92.4% of Phase 3 subjects from this trial into the open-label, long-term safety study*
- Conference call and webcast on March 15, 2023 at 8:00 a.m. ET
LONG BEACH, Calif. and BASEL, Switzerland, March 15, 2023 (GLOBE NEWSWIRE) -- Dermavant Sciences, a Roivant Sciences (Nasdaq: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced positive results from ADORING 2, one of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and safety of topical VTAMA (tapinarof) cream, 1% in pediatric subjects down to 2 years old and adult subjects with atopic dermatitis (AD).
In ADORING 2 (N=406), VTAMA cream met the primary endpoint of the trial and demonstrated highly statistically significant improvement in the vIGA-AD score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).
Additionally, VTAMA cream demonstrated highly statistically significant improvement in the proportion of subjects with >75% improvement in EASI75 from baseline at week 8 (P<0.0001), a key secondary endpoint. Subjects 12 years and older receiving VTAMA cream also experienced a highly statistically significant improvement >4-point reduction in Peak Pruritis Numeric Rating Scale (PP-NRS) in itch (P=0.0015), another key secondary endpoint in the study due to its prevalence among AD sufferers.
Table 1: ADORING 2 Phase 3 Trial – Primary and Key Secondary Endpoints
| ADORING 2 Week 8 |
Endpoint | VTAMA 1% QD | Vehicle QD
| P value |
vIGA-AD success1 | 46.4% | 18.0% | <0.0001 |
EASI752 | 59.1% | 21.2% | <0.0001 |
≥4-point reduction in PP-NRS3 | 52.8% | 24.1% | 0.0015 |
1Primary Endpoint: Proportion of subjects who achieved a vIGA-AD score of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8.
2Secondary Endpoint: Proportion of subjects with >75% improvement in EASI from baseline at Week 8.
3Secondary Endpoint: Proportion of subjects ≥12 years old with a baseline PP-NRS score ≥4 who achieve ≥ 4-point reduction in the PP-NRS from baseline at Week 8.
Both adult and pediatric AD subjects receiving VTAMA cream, 1% did so at the same dose and dose regimen as already approved for adults with plaque psoriasis. Subject to FDA approval in AD, the company believes this could be a key manufacturing, supply chain, and commercial advantage, offering simplicity of treatment to both physicians, pharmacists, and patients, regardless of diagnosis.
"We are highly encouraged by the positive results from ADORING 2, which suggests VTAMA cream can be a potentially important non-steroidal, topical treatment option for atopic dermatitis patients, including children as young as two years old where we know there is a compelling need," said Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant. "Atopic dermatitis, the most common type of eczema, affects more than 9.6 million children and 16.5 million adults in the United States. The majority of patients diagnosed with atopic dermatitis suffer from severe itching and scratching resulting in skin redness, and damage to the skin barrier, which is why any effective therapeutic for AD needs to tackle the issue of pruritus, especially in a pediatric population.** We now keenly anticipate topline data from our identically designed ADORING 1 trial in May 2023."
VTAMA cream is a novel, aryl hydrocarbon receptor agonist, in development as a once-daily, steroid-free, and cosmetically elegant topical cream for the treatment of AD. In the U.S., VTAMA cream is already approved for the topical treatment of plaque psoriasis in adults.
Topline Results
In ADORING 2, pediatric and adult subjects with atopic dermatitis were randomized at a 2:1 ratio to receive once daily (QD) treatment with VTAMA cream, 1% or vehicle cream.
- At week 8, 46.4% of subjects treated with VTAMA cream in ADORING 2 achieved the primary endpoint of a vIGA-AD of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8 (P<0.0001).
- Also at week 8, 59.1% of subjects treated with VTAMA cream in ADORING 2 achieved the key secondary endpoint of the proportion of subjects with >75% improvement in EASI (P<0.0001).
- 52.8% of subjects ≥12 years old, with a baseline PP-NRS score ≥4, achieved a ≥4-point reduction in the PP-NRS at Week 8 (P=0.0015).
- Importantly, VTAMA cream data indicated no safety or tolerability signals in this population including children as young as 2 years old. Adverse events were mild to moderate with a low study discontinuation rate due to adverse events (1.5% VTAMA vs. 3.0% vehicle).
- Adverse events of special interest included contact dermatitis (1.1% VTAMA vs. 1.5% vehicle) and follicular event (8.9% VTAMA vs. 1.5% vehicle).
"Atopic dermatitis can have a negative impact on the quality of life of diagnosed children as well as their families. Both the efficacy and itch data from the ADORING 2 trial are highly encouraging in this regard, pointing to VTAMA cream as a potential non-steroidal topical treatment option for AD that is safe and well tolerated in children," said Lawrence Eichenfield, M.D. Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego. "Importantly, the potential to use the same dose regimen with VTAMA cream for children and adults with AD offers treatment simplicity for prescribers, helped even more by the fact that it is the same regimen already being used for plaque psoriasis."
"The topline results from ADORING 2 underscore VTAMA cream as a potential well-tolerated therapeutic with a favorable safety profile," said Linda Stein Gold, M.D., Director of Clinical Research and the Division Head of Dermatology at the Henry Ford Health System. "When one considers this Phase 3 data alongside the recently reported pediatric maximal usage pharmacokinetic (MUPK) AD study, which in treated patients demonstrated minimal-to-no-systemic exposure despite heavy disease burden, VTAMA cream is positioning itself to be a potential two-in-one first-line topical treatment for both atopic dermatitis and plaque psoriasis."
Dermavant recently released highly favorable results from a pediatric maximal usage pharmacokinetics (MUPK) study of VTAMA cream in AD. The study demonstrated minimal-to-no systemic exposure despite maximal use. In addition, subjects were as young as 2 years old with up to 90% body surface area (BSA) affected with a mean BSA of 43%.
On May 24, 2022, Dermavant announced the FDA approved VTAMA (tapinarof) cream, 1% for the treatment of adult plaque psoriasis. 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 approved for mild, moderate, and severe plaque psoriasis - with no label safety warnings or precautions, restrictions on duration of use or body surface area. On July 15, 2022, VTAMA cream became the #1 prescribed branded topical treatment for plaque psoriasisi and to date has over 110,000 prescriptions written with over 9,300 unique prescribers†.
Conference Call
Roivant will host a conference call and a live webcast on March 15, 2023 at 8:00 am ET to discuss the positive ADORING 2 topline results.
To access the conference call by phone, please register online using this registration link. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at The archived webcast will be available on Roivant's website after the conference call.
About Roivant Sciences
Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies. For more information, please visit .
Roivant Sciences Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our products and product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our products and product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
IMPORTANT SAFETY INFORMATION
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).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
See full Prescribing Information and Patient Information.
About Dermavant's Phase 3 Program for VTAMA cream in Atopic Dermatitis
ADORING is Dermavant's pivotal Phase 3 atopic dermatitis (AD) clinical program for VTAMA (tapinarof) cream, 1%, which consists of ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859), as well as ADORING 3 (NCT05142774), an open-label, long-term extension study.
About Atopic Dermatitis
Atopic dermatitis (AD), commonly referred to as eczema, is one of the most common inflammatory skin diseases, affecting 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 30% 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. 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.
About 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. The company's medical dermatology pipeline includes commercialized, late-stage and earlier-development 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. 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 is also developing VTAMA cream, 1% for the treatment of atopic dermatitis in adults and children and released topline results from its Phase 3 clinical trial, ADORING 2, in March 2023. Dermavant expects to release topline results from its second, identical Phase 3 clinical trial for atopic dermatitis, ADORING 1, in May 2023. Dermavant's pipeline includes DMVT-506, a next generation aryl hydrocarbon receptor (AhR) agonist under development as a potential differentiated treatment option for immunological and inflammatory diseases with multiple potential routes of administration.
For more information, please visit and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).
*Dermavant DOF March 2023.
**National Eczema Association. Atopic Dermatitis.
iIQVIA National Prescription Audit (NPA) for the 3-month period ending 2/24/2023, reflecting estimates of real-world activity. All rights reserved.
†NPA for the period 5/20/22 to 3/3/2023, reflecting estimates of real-world activity. All rights reserved.
2023 Dermavant Sciences, Inc. All Rights Reserved. VTAMA is the registered trademark of Dermavant Sciences, GmbH. vIGA-AD(TM) is the trademark of Eli Lilly and Co.
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Roivant Sciences
stephanie.lee@roivant.com
- 在接受 VTAMA 乳膏的受试者中,有 46.4% 达到了经过验证的过敏性皮炎研究者全球评估 (Viga-AD) 的主要终点TM) 响应清晰 (0) 或几乎清晰 (1),与第 8 周的基线相比至少提高 2 级,而车辆的反应为 18.0%(P<0.0001)
- 所有次要终点均达到高度的统计学意义,包括在接受 VTAMA 乳膏治疗的受试者中,有 59.1% 达到 EASI75 的关键次要终点(P<0.0001)
- 对瘙痒(痒)的关键次要终点产生了有意义的影响,52.8%的受试者年龄在12岁以上,PP-NRS的基线分数≥4,在第8周,PP-NRS降低了≥4个百分点(P = 0.0015)
- 该试验的3期受试者中有92.4%转入开放标签的长期安全性研究*
- 美国东部时间 2023 年 3 月 15 日上午 8:00 的电话会议和网络直播
加利福尼亚州长滩和瑞士巴塞尔,2023年3月15日(GLOBE NEWSWIRE)——致力于开发和商业化免疫皮肤病学创新疗法的Roivant Sciences(纳斯达克股票代码:ROIV)公司Dermavant Sciences今天宣布了评估局部VTAMA疗效和安全性的两项双盲、随机、载体对照的3期研究之一 ADORING 2的积极结果 (tapinarof)乳膏,在2岁以下的儿科受试者和患有特应性皮炎(AD)的成年受试者中为1%。
在ADORING 2(N=406)中,VTAMA面霜达到了试验的主要终点,并显示出Viga-AD分数(透明(0)或几乎透明(1)的显著改善,与第8周的基线相比至少提高了2个等级(P<0.0001)。
此外,VTAMA 面霜的受试者比例在统计学上显示出高度显著的改善 >EASI75 比第 8 周的基线提高了 75%(P<0.0001),这是关键的次要终点。12 岁及以上接受 VTAMA 面霜的受试者在统计学上也取得了非常显著的改善 >瘙痒(P = 0.0015)的瘙痒峰值数字评级量表(PP-NRS)降低了4个百分点,这是该研究的另一个关键次要终点,因为其在AD患者中的患病率。
表 1:ADORING 2 第 3 阶段试验 — 主要和关键次要终点
| 崇拜 2 第 8 周 |
端点 | VTAMA 1% QD | 车辆 QD
| P 值 |
Viga-Ad 的成功1 | 46.4% | 18.0% | <0.0001 |
EASI752 | 59.1% | 21.2% | <0.0001 |
PP-NRS 降低了 ≥4 个百分点3 | 52.8% | 24.1% | 0.0015 |
1主要终点:在第 8 周获得清除 (0) 或几乎清除 (1) 的 Viga-AD 分数比基线至少提高 2 级的受试者比例。
2次要终点:具有以下特征的受试者比例 >EASI 比第 8 周的基线提高了 75%。
3次要终点:在年龄≥12岁、基线PP-NRS分数≥4的受试者中,在第8周的PP-NRS比基线降低了≥4个百分点的受试者比例。
接受VTAMA乳膏的成人和儿童AD受试者中,有1%的剂量和剂量方案与已经批准的斑块状银屑病成人相同。该公司认为,这可能是一项关键的制造、供应链和商业优势,无论诊断如何,都能为医生、药剂师和患者提供简便的治疗,但须获得美国食品药品管理局的批准。
Dermavant首席医学官Philip M. Brown医学博士、法学博士菲利普·布朗说:“ADORING 2的积极结果令我们深受鼓舞,这表明VTAMA霜可以成为特应性皮炎患者的潜在重要非甾体局部治疗选择,包括年仅两岁的儿童。”“特应性皮炎是最常见的湿疹类型,在美国影响了超过960万儿童和1,650万成年人。大多数被诊断患有特应性皮炎的患者会出现严重的瘙痒和抓伤,从而导致皮肤发红和皮肤屏障受损,这就是为什么任何有效的AD治疗都需要解决瘙痒问题,尤其是在儿科人群中。** 现在,我们敏锐地预计2023年5月将从我们设计相同的ADORING 1试验中获得顶级数据。”
VTAMA 乳霜是一种新型的芳基碳氢化合物受体激动剂,正在开发中,是一种用于治疗 AD 的每日一次、不含类固醇、外观优雅的外用乳膏。在美国,VTAMA霜已被批准用于成人斑块状牛皮癣的局部治疗。
头条业绩
在 ADORING 2 中,以 2:1 的比例随机分配患有特应性皮炎的儿科和成人受试者,使用VTAMA乳膏、1%或载体霜接受每日一次(QD)治疗。
- 在第8周,在ADORING 2中接受VTAMA霜治疗的受试者中,有46.4%的受试者达到了Viga-ad为透明(0)或几乎透明(1)的主要终点,与第8周的基线相比至少改善了2级(P<0.0001)。
- 同样在第8周,在ADORING 2中接受VTAMA霜治疗的受试者中有59.1%达到了关键的次要终点,即接受VTAMA乳膏治疗的受试者比例 >EASI 提高了 75%(P<0.0001)。
- 在12岁以上、PP-NRS基线分数≥4的受试者中,有52.8%在第8周的PP-NRS降低了≥4个百分点(P = 0.0015)。
- 重要的是,VTAMA乳膏数据表明,包括年仅2岁的儿童在内的该人群中没有安全性或耐受性信号。不良事件为轻度至中度,不良事件导致的研究中止率较低(VTAMA为1.5%,车辆为3.0%)。
- 特别令人关注的不良事件包括接触性皮炎(VTAMA为1.1%,载体为1.5%)和滤泡事件(VTAMA为8.9%,载体为1.5%)。
“特应性皮炎会对被诊断儿童及其家庭的生活质量产生负面影响。在这方面,ADORING 2试验的疗效和瘙痒数据都非常令人鼓舞,指出VTAMA霜是治疗AD的潜在非甾体局部治疗选择,对儿童安全且耐受性良好。” 圣地亚哥雷迪儿童医院儿科和青少年皮肤科主任劳伦斯·艾琴菲尔德医学博士说。“重要的是,对于患有AD的儿童和成人,使用相同剂量的VTAMA乳膏的治疗方案为处方者提供了简便的治疗方法,而治疗斑块状牛皮癣的方案与已经使用的治疗方案相同,这一事实更有助益。”
亨利·福特卫生系统临床研究主任兼皮肤科主任琳达·斯坦·戈德医学博士说:“ADORING 2的主要结果突显了VTAMA霜是一种潜在的耐受性良好的治疗药物,具有良好的安全性。”“当人们将这3期数据与最近报告的儿科最大使用药代动力学(MUPK)AD研究一起考虑时,尽管疾病负担沉重,但该研究在接受治疗的患者中表现出最低甚至没有全身暴露,VTAMA乳膏将自己定位为潜在的异位性皮炎和斑块状牛皮癣的二合一一一一局部治疗药物。”
Dermavant最近发布了一项针对AD VTAMA乳膏的儿科最大使用药代动力学(MUPK)研究,结果非常好。该研究表明,尽管最大限度地使用了全身暴露,但全身暴露量很小甚至没有。此外,受试者年仅2岁,受影响的体表面积(BSA)高达90%,平均BSA为43%。
2022年5月24日,Dermavant宣布美国食品药品管理局批准的VTAMA(tapinarof)乳膏为1%,用于治疗成人斑块状牛皮癣。该批准使VTAMA霜成为25年多来在美国推出的首个治疗银屑病的非甾体外用新型化学药物。VTAMA 乳膏获准用于轻度、中度和重度斑块状牛皮癣——无标签安全警告或预防措施,对使用时间或体表面积有限制。2022 年 7 月 15 日,VTAMA 霜成为治疗斑块状牛皮癣的 #1 处方品牌局部治疗药物我 迄今为止,已经有超过9,300名独立处方者开了超过11万张处方†。
电话会议
Roivant将于美国东部时间2023年3月15日上午8点主持电话会议和网络直播,讨论ADORING 2的积极业绩。
要通过电话参加电话会议,请使用此注册链接在线注册。电话会议的网络直播也将在Roivant网站投资者部分的 “活动与演讲” 下提供。电话会议结束后,存档的网络直播将在Roivant的网站上播出。
关于 Roivant Scien
Roivant 的使命是通过将每一次效率低下视为机会来改善向患者提供的医疗服务。Roivant通过构建技术和以创造性的方式培养人才,利用Roivant平台创办灵活而专注的生物制药和健康技术公司Vants来更快地开发变革性药物。欲了解更多信息,请访问。
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本新闻稿包含前瞻性陈述。本新闻稿中的陈述可能包括非历史事实的陈述,根据经修订的1933年《证券法》(“证券法”)第27A条和经修订的1934年《证券交易法》(“交易法”)第21E条,这些陈述通常使用 “预期”、“相信”、“继续”、“可以”、“估计” 等词语来识别” “期望”、“打算”、“可能”、“可能”、“计划”、“可能”、“潜力”、“预测”、“项目”、“应该”、“将” 以及此类词语的变体或相似的表达式。这些词语可以识别前瞻性陈述,但缺少这些词并不意味着陈述不是前瞻性陈述。我们打算在《证券法》第27A条和《交易法》第21E条中包含的前瞻性陈述的安全港条款中涵盖这些前瞻性陈述。
我们的前瞻性陈述包括但不限于关于我们或我们的管理团队对未来的期望、希望、信念、意图或战略的陈述,以及非历史事实的陈述,包括关于我们产品和候选产品的临床和治疗潜力、我们正在进行的临床试验的主要结果的可用性和成功以及我们的产品和候选产品的任何商业潜力的陈述。此外,任何提及未来事件或情况的预测、预测或其他特征的陈述,包括任何基本假设,均为前瞻性陈述。
尽管我们认为这些前瞻性陈述所反映或建议的计划、意图、期望和战略是合理的,但我们无法保证这些计划、意图、期望或战略能够实现或实现。此外,实际结果可能与前瞻性陈述中描述的结果存在重大差异,并将受到许多风险、不确定性和假设的影响,包括但不限于我们在向美国证券交易委员会提交的文件的 “风险因素” 部分中列出的风险。此外,我们在竞争激烈且瞬息万变的环境中运营,在这种环境中,不时出现新的风险。这些前瞻性陈述基于截至本新闻稿发布之日我们管理层当前的预期和信念,并受某些风险和不确定性的影响,这些风险和不确定性可能导致实际业绩与前瞻性陈述中描述的结果存在重大差异。除非适用法律要求,否则我们没有义务公开更新任何前瞻性陈述,无论是由于新信息、未来事件还是其他原因。
重要的安全信息
指示: VTAMA (tapinarof)乳膏,1% 是一种芳基碳氢化合物受体激动剂,适用于局部治疗成人斑块状牛皮癣。 不良事件:在接受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(毛孔周围有红色凸起的肿块)、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)。
鼓励您向FDA报告处方药的负面副作用。访问或致电 1-800-FDA-1088。
查看完整的处方信息和患者信息。
关于 Dermavant 针对过敏性皮炎的 VTAMA 乳膏的第三阶段计划
ADORING是Dermavant针对VTAMA(tapinarof)乳膏的关键3期特应性皮炎(AD)临床项目,占1%,包括ADORING 1(NCT05014568)和ADORING 2(NCT05032859),以及一项开放标签的长期延期研究ADORING 3(NCT05142774)。
关于特应性皮炎
过敏性皮炎(AD),通常被称为湿疹,是最常见的炎症性皮肤病之一,仅在美国就有超过2600万人受到影响,全球有多达10%的成年人受到影响。AD 最常发生在儿童身上,在全球范围内影响高达 30%。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、膝盖后部、手、脸部和颈部的褶皱。瘙痒是AD中特别令人困扰的症状,在夜间往往会恶化,干扰睡眠并引起疲劳,这可能导致儿童注意力不集中。AD 患者还可能因为疾病的可见性和不适感而经历社交和情感上的困扰。
关于 Dermavant
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领域的创新疗法。Dermavant的重点是开发有可能解决高度未得到满足的医疗需求的疗法,同时提高研究和临床开发的效率。该公司的医疗皮肤科产品线包括商业化、后期和早期开发的候选产品,这些候选产品针对的是两个最大的成长型免疫皮肤病市场,即斑块状银屑病和特应性皮炎以及其他免疫和炎症性疾病中未得到满足的特定需求。Dermavant 正在推销 VTAMA (tapinarof)乳膏,1%,用于局部治疗成人斑块状牛皮癣。美国食品药品管理局于2022年5月批准VTAMA Cream用于局部治疗轻度、中度和重度斑块状牛皮癣。Dermavant还在开发VTAMA乳膏,价格为1%,用于治疗成人和儿童过敏性皮炎,并于2023年3月发布了其3期临床试验ADORING 2的主要结果。Dermavant预计将于2023年5月公布其第二项相同的异位性皮炎3期临床试验ADORING 1的主要结果。Dermavant 的产品线包括 DMVT-506,这是一种正在开发的下一代芳基碳氢化合物受体 (aHR) 激动剂,是具有多种潜在给药途径的免疫学和炎症性疾病的潜在差异化治疗选择。
欲了解更多信息,请在 Twitter (@dermavant) 和 LinkedIn(Dermavant Sciences)上访问并关注我们。
*Dermavant DOF 2023 年 3 月。
**全国湿疹协会。过敏性皮炎。
我IQVIA全国处方审计(NPA),为期3个月,截至2023年2月24日,反映了对现实世界活动的估计。版权所有。
†2022年5月20日至2023年3月3日期间的NPA,反映了对现实世界活动的估计。版权所有。
2023 Dermavant Sciences, Inc. 版权所有。VTAMA 是 Dermavant Sciences, GmbH 的注册商标。Viga-ad (TM) 是 Eli Lilly and Co. 的商标
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