- 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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- 46.4% 接受 VTAMA 霜的受試者中,1% 實現了經過驗證的研究者特應性皮炎全球評估(VIGA-AD)的主要終點TM)清晰(0)或幾乎清晰(1)的響應,從第 8 週的基線至少有 2 級改善,而車輛上的 18.0%(P<0.0001)
- 所有次要終點都具有高度的統計意義,其中包括使用 VTAMA 霜治療的受試者的 59.1%,他們實現了 EASI75 的關鍵二級終點(P<0.0001)
- 顯示對關鍵次要瘙癢終點有意義的影響 (癢),在 ≥12 歲的受試者中,有 52.8% 的受試者,PP-NRS 的基準分數 ≥4,在第 8 週實現 PP-NRS 減少 ≥4 分(P=0.0015)
- 從這項試驗到開放標籤的長期安全研究中,第 3 階段受試者的翻轉率為 92.4%*
- 於美國東部時間 2023 年 3 月 15 日上午 8:00 舉行的電話會議和網路廣播
加州長灘和瑞士巴塞爾,2023 年 3 月 15 日(全球新聞社)-魯瓦特科學(納斯達克股票代碼:ROIV)公司,致力於開發和商業化免疫皮膚科創新療法,今天宣布 ADORING 2 的雙盲隨機車輛對照 3 期研究之一的積極結果,以評估 VTAMA 的主題效果和安全性。 (Tapinarin) 奶油, 1% 在兒科受試者到 2 歲和成人受試者與特應性皮炎 (AD).
在崇拜 2(N = 406)中,VTAMA 霜達到了試驗的主要終點,並在第 8 週(P <0.0001)的 VIGA-AD 分數顯著提高了明確(0)或幾乎清晰(1)的基線至少有 2 級改善。
此外,VTAMA 乳霜在受試者的比例上表現出了非常顯著的統計學改善 >EASI75 從關鍵次要端點第 8 週 (P <0.0001) 的基準線改善了 75%。接受 VTAMA 霜的 12 歲及以上的受試者也經歷了非常顯著的統計學改善 >4 點降低峰值普魯里提數字評級表 (PP-NRS) 癢 (P=0.0015), 在研究中的另一個關鍵的次要終點,由於其在 AD 患者中的患病率.
表 1:遵守 2 第 3 階段試驗 — 主要和金鑰次要端點
| 崇拜 2 第八週 |
端點 | 平均 1% 平方數 | 車輛 QD
| P 值 |
VIGA-AD 成功的廣告1 | 46.4% | 18.0% | <0.0001 |
輕鬆 752 | 59.1% | 21.2% | <0.0001 |
減少 ≥4 點的 PP-NRS3 | 52.8% | 24.1% | 0.0015 |
1主要終點:在第 8 週的 VIGA-AD 分數達到清晰 (0) 或幾乎清晰 (1) 且至少有 2 年級改善的受試者比例。
2次要終點:受試者的比例 >從第 8 週的基線開始,EASI 的改善 75%。
3次要終點:≥12 歲且基線 PP-NRS 分數 ≥4 的受試者的比例,他們在第 8 週從基線起 PP-NRS 減少 ≥ 4 分。
接受 VTAMA 霜的成人和兒童 AD 受試者,1% 的劑量和劑量方案已經批准用於牙菌斑牛皮癬的成年人。在獲得 AD FDA 批准後,該公司認為這可能是一項關鍵的製造、供應鏈和商業優勢,無論診斷如何,都能為醫師、藥劑師和患者提供簡單的治療方式。
Dermavant 首席醫療官醫師菲利普·布朗(Philip M Brown)表示:「ADORing 2 的積極結果對我們感到高度鼓舞,這表明 VTAMA 霜可能是一種潛在重要的非類固醇,局部治療選擇對特應性皮炎患者,包括兩歲以下的兒童,我們知道有一個令人信服的需求。「特應性皮炎是最常見的濕疹類型,在美國影響了超過 960 萬名兒童和 1650 萬成年人。大多數被診斷患有特應性皮炎的患者都會遭受嚴重的瘙癢和刮傷,導致皮膚紅腫以及皮膚屏障的損害,這就是為什麼對 AD 進行任何有效治療都需要解決瘙癢問題的原因,尤其是在兒童群體中。** 現在,我們非常期待 2023 年 5 月從我們設計完全相同的 ADORing 1 試驗中獲得頂線數據。」
VTAMA 霜是一種新穎的芳基烴受體激動劑,作為每日一次,不含類固醇和美觀優雅的外用霜,用於治療 AD。在美國,VTAMA 霜已被批准用於成人斑塊牛皮癬的局部治療。
頂線結果
在崇拜 2 中,患有特應性皮炎的兒科和成年受試者以 2:1 的比例隨機分配,每天接受一次(QD)VTAMA 霜,1% 或車用霜治療。
- 在第 8 週,在崇拜 2 中使用 VTAMA 乳膏治療的受試者中,46.4% 實現了清晰(0)或幾乎清晰(1)的 Viga-AD 的主要終點,至少從第 8 週(P<0.0001)的基線進行了 2 級改善。
- 同樣在第 8 週,在崇拜 2 中使用 VTAMA 霜治療的受試者中,59.1% 實現了受試者比例的關鍵次要終點 >歐洲資訊安全指數的改善率達 75% (P <0.0001)。
- 52.8% 的年齡在 12 歲以上的受試者中,PP-NRS 基線分數 ≥4 分,在第八週的 PP-NRS 減少了 ≥4 分(P =0.0015)。
- 重要的是,VTAMA 霜數據表明,包括 2 歲以下兒童在內的這個人群中沒有安全性或耐受性信號。不良事件輕度至中度,由於不良事件導致的研究停藥率低(1.5% VTAMA 與 3.0% 車輛)。
- 特殊興趣的不良事件包括接觸性皮炎(1.1% VTAMA 對 1.5% 車輛)和濾泡事件(8.9% VTAMA 與 1.5% 車輛)。
「特應性皮炎可以對被診斷兒童及其家庭的生活質量產生負面影響。在這方面,ADORing 2 試驗的療效和瘙癢數據都非常令人鼓舞,指出 VTAMA 霜是 AD 的潛在非類固醇局部治療選擇,這對兒童來說安全且耐受性良好。」「重要的是,可能使用與 VTAMA 奶油相同劑量的方案用於兒童和成人,AD 為處方者提供治療簡單性,因為它是已經用於斑塊狀牛皮癬的相同方案,這一事實更有幫助。」
亨利·福特健康系統臨床研究主任兼皮膚科主任 Linda Stein Gold 醫學博士表示:「ADORING 2 的頂級結果強調了 VTAMA 霜作為一種潛在的耐受性良好的治療方法,具有良好的安全性。「當人們認為這 3 階段數據與最近報導的兒科最大使用藥代動力學(MUPK)AD 研究一起考慮時,儘管嚴重的疾病負擔,但在治療過的患者中,儘管嚴重的疾病負擔,VTAMA 霜將自己定位為潛在的二合一一一局部治療特應性皮炎和斑塊性牛皮癬。」
Dermavant 最近發布了非常有利的結果,從兒科最大使用藥代動力學(MUPK)在公元中對 VTAMA 霜的研究。該研究表明,儘管最大程度地使用,但最小至沒有全身暴露。此外,受試者還年輕 2 歲,最多 90% 的體表面積 (BSA) 受影響,平均 BSA 為 43%。
2022 年 5 月 24 日,德馬凡特宣布美國食品和藥物管理局批准的 VTAMA 乳霜,用於治療成人斑塊牛皮癬的 1%。該批准使 VTAMA 霜成為美國第一個用於牛皮癬的非甾體外用新型化學實體,已超過 25 年。VTAMA 乳霜經批准用於輕度,中度和嚴重的斑塊狀牛皮癬-沒有標籤安全警告或注意事項,限制使用時間或體表面積。2022 年 7 月 15 日,VTAMA 面霜成為 #1 規定的斑塊牛皮癬品牌局部治療我 迄今為止,擁有超過 110,000 個處方,其中包含 9,300 多個獨特的處方者†。
電話會議
Roivant 將於 2023 年 3 月 15 日美國東部時間上午 8:00 舉辦電話會議和網路直播,討論積極的 ADORing 2 頂線結果。
要通過電話訪問電話會議,請使用此註冊鏈接在線註冊。電話會議結束後,您也可以在 Roivant 網站「投資人」部分的「活動和演示文稿」下提供該電話會議的網絡廣播。存檔的網絡廣播將在 Roivant 的網站上提供。
關於雷萬特科學
Roivant 的使命是通過將每一次低效率視為機會,改善向患者提供醫療保健服務。Roivant 通過建立技術和以創造性的方式發展人才,利用 Roivant 平台推出 Vants(靈活且專注的生物製藥和健康科技公司),從而更快地開發變革性藥物。欲了解更多信息,請訪問。
洛夫科學前瞻性陳述
本新聞稿載有前瞻性陳述。本新聞稿中的聲明可能包括不是歷史事實的陳述,並被認為是經修訂的 1933 年證券法第 27A 節(「證券法」),以及經修訂的 1934 年證券交易法第 21E 條(「交易法」)的第 21E 條,通常通過使用「預期」,「可以相信」,「可以相信」「估計」,「期望」,「意圖」,「可能」,「可能」,「計劃」,「可能」,「潛在」,「預測」,「項目」,「應」,「應」,「會」和這些單詞的變化或類似的表達式。這些詞語可以識別前瞻性陳述,但是沒有這些詞語並不意味著陳述並不是前瞻性的。我們打算這些前瞻性陳述涵蓋在《證券法》第 27A 條和《交易所法》第 21E 條中包含的前瞻性陳述的安全港條款。
我們的前瞻性陳述包括但不限於關於我們或我們的管理團隊對未來的期望、希望、信念、意圖或策略的陳述,以及不屬於歷史事實的陳述,包括關於我們產品和候選產品的臨床和治療潛力的陳述,以及我們正在進行的臨床試驗和產品候選產品的任何商業潛力的可用性和成功。此外,任何涉及未來事件或情況的預測,預測或其他特徵的陳述,包括任何基礎假設,都是前瞻性陳述。
雖然我們相信我們的計劃、意向、期望和策略反映在前瞻性陳述中或建議是合理的,但我們不能保證有關的計劃、意圖、期望或策略會達致或達致。此外,實際結果可能與前瞻性陳述中描述的重大差異,並會受到一些風險、不確定性和假設的影響,包括但不限於我們向美國證券交易委員會提交的風險因素一節中列出的風險。此外,我們在一個極具競爭力和快速變化的環境中運作,在這種環境中不時出現新的風險。這些前瞻性陳述是根據本新聞稿發佈日期我們管理層目前的期望和信念,並且受到某些風險和不確定性的影響,這些風險和不確定性可能導致實際結果與前瞻性陳述中描述的結果有很大不同。除適用法律要求外,我們沒有義務公開更新任何前瞻性聲明,無論是因為新資訊、未來事件或其他原因造成的。
重要安全資訊
指示: VTAMA (tapinarin)奶油,1% 是芳烴受體激動劑,用於局部治療成人斑塊牛皮癬。 不良事件:使用 VTAMA 膏治療的受試者最常見的不良反應(發病率 ≥ 1%)是毛囊炎(毛孔周圍的紅色凸起凸起)、鼻咽炎(鼻子和咽喉疼痛或腫脹)、接觸性皮炎(皮疹或刺激性,包括瘙癢和發紅、脫皮、灼熱或刺痛)、頭痛、瘙癢(瘙癢)、流感(瘙癢)。
我們鼓勵您向 FDA 報告處方藥的負面副作用。請造訪或致電 1-800-FDA-1088。
請參閱完整的處方資訊和患者資訊。
關於德馬文特針對特應性皮炎中的 VTAMA 霜的第三期計劃
崇拜是德馬文的關鍵階段 3 特應性皮炎 (AD) 臨床計劃 VTAMA (腰帶) 奶油, 1%, 其中包括崇拜 1 (NCT05014568) 和崇拜 2 (NCT05032859), 以及崇拜 3 (NCT05142774), 一個開放的標籤, 長期擴展研究.
關於特應性皮炎
特應性皮炎(AD)通常被稱為濕疹,是最常見的炎性皮膚疾病之一,僅在美國就影響了 2,600 萬人,全球有多達 10% 的成年人。AD 最常發生在兒童身上,影響到全球範圍內高達 30%。這種疾病會導致皮膚瘙癢,發紅,腫脹和破裂,通常會影響手臂,膝蓋背部,手部,臉部和頸部的褶皺。瘙癢是 AD 中一種特別令人煩惱的症狀,晚上往往會惡化,令睡眠不安並引起疲勞,這在兒童中可能導致學校注意力不集中。由於疾病的可見性和不適,患有 AD 患者也可能會遇到社交和情緒困擾。
關於德馬旺
Dermavant Sciences 是 Roivant Sciences 的子公司,是一家生物製藥公司,致力於開發和商業化免疫皮膚科領域的創新療法。Dermavant 的重點是開發有潛力解決高尚未滿足醫療需求的療法,同時提高研究和臨床開發效率。該公司的醫學皮膚病學產品線包括商業化、後期和早期開發的候選產品,這些候選產品針對在日益增長的兩個最大的免疫-皮膚病市場(即斑塊狀牛皮癬和特應性皮炎以及其他免疫和炎症性疾病)中的特定未滿足需求。最好的是營銷活動 (tapinarin)奶油,1%,用於成人牙菌斑牛皮癬的局部治療。美國食品和藥物管理局 (FDA) 批准 VTAMA 面霜,用於 2022 年 5 月局部治療輕度、中度和嚴重斑塊狀牛皮癬。Dermavant 還正在開發 VTAMA 霜,用於治療成人和兒童特應性皮炎的 1%,並在 2023 年 3 月 2 日從其 3 期臨床試驗中釋放了頂線結果。Dermavant 預計將於 2023 年 5 月釋放第二次針對特應性皮炎相同 3 期臨床試驗的頂峰結果。Dermavant 的管道包括 DMVT-506,這是一種正在開發的下一代芳基烴受體(AhR)激動劑,用於具有多種潛在給藥途徑的免疫學和炎症性疾病的潛在差異化治療選擇。
欲了解更多信息,請訪問並關注我們的推特(@dermavant)和領英(德馬凡特科學)。
*從 2023 年 3 月開始的自由度。
**國家濕疹協會。特應性皮炎。
我IQVIA 國家處方審計(NPA)為期 3 個月,截至 2023 年 2 月 24 日,反映了對真實世界活動的估計。保留所有權利。
†NPA 期間為 5/20/22 至 2023 年 3 月 3 日,反映了對真實世界活動的估計。保留所有權利。
2023 德馬文特科學公司保留所有權利。VTAMA 是德馬萬特科學有限公司的註冊商標。VIGA-AD(TM)是禮來公司和有限公司的商標。
联系人
投資者
理財投資者關係
ir@roivant.com
媒體
斯蒂芬妮·李
洛万特科学
stephanie.lee@roivant.com