- ZORYVE cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trials
- Roflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile for up to 56 weeks of treatment
- Approximately 1.8 million children with atopic dermatitis (AD) aged 2 to 5 are topically treated in the United States
WESTLAKE VILLAGE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZORYVE (roflumilast) cream 0.05%, a once-daily, next generation phosphodiesterase 4 (PDE4) inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old.
"When choosing a therapy for very young children living with AD, healthcare providers and caregivers have to account for unique considerations for pediatric patients, including sensitive skin, and select a medication that is appropriate for long-term use by a child with a chronic skin condition. Data from the pivotal trial demonstrated that roflumilast cream 0.05% provided consistent and rapid relief, and was well-tolerated," said Rocco Serrao, MD, FAAD, of DOCS Dermatology and INTEGUMENT-PED and INTEGUMENT-OLE investigator. "If approved, roflumilast cream 0.05% would offer a new topical option with the potential to advance the standard of care for these young patients, offering fast relief to the children and their families from the onerous symptoms of AD."
AD is a chronic, genetically predisposed, relapsing inflammatory skin disease that presents across the lifespan. The disease may appear as a red, intensely itchy rash that can occur anywhere on the body and may present differently in children and adults. Pediatric AD can negatively impact the quality of life of the child as well as their family or caregivers.
"Parents, caregivers, and healthcare professionals need to feel confident in their treatment plan. Our clinical development program for ZORYVE reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream, which was designed to deliver drug without disrupting the skin barrier or using sensitizing excipients and irritants. This lower concentration of roflumilast cream was intentionally formulated for the needs of younger children with AD and demonstrates our commitment to serving this vulnerable patient population," said Frank Watanabe, president and CEO of Arcutis. "We look forward to the opportunity to offer ZORYVE cream 0.05%, if approved, as a new topical therapy for the 1.8 million children between the ages of 2 to 5 with AD and their families."
The sNDA is supported by positive results from one pivotal Phase 3 trial, one pivotal long-term extension study, as well as a Phase 1 pharmacokinetic study. The INTEGUMENT-PED vehicle-controlled, pivotal Phase 3 trial enrolled 652 children 2 to 5 years of age, with a mean AD Body Surface Area (BSA) of 22% overall, and ranging from 3% to 82%. In the study, at Week 4, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle (P<0.0001), with significant improvements seen as early as Week 1. All secondary endpoints were also met, with significant improvements seen across all time points, including vIGA-AD success and vIGA-AD of 'Clear' and 'Almost Clear' at Week 1. In addition, 35.3% of children treated with roflumilast cream who had a baseline Worst Itch Numeric Scale (WI-NRS) score ≥4 (as reported by the caregiver) achieved a four-point reduction in WI-NRS at Week 4 (vs. 18.0% for vehicle-treated children [nominal P=0.0002]).
Roflumilast cream 0.05% was well-tolerated. Overall, the safety profile observed in 2‐ to 5‐year‐old pediatric subjects treated with ZORYVE cream 0.05% during the trial was consistent with the favorable safety profile established in adults and older pediatric subjects treated with ZORYVE cream 0.15% with mild to moderate AD. The most frequent adverse events occurring in the roflumilast arm greater than vehicle (≥2%) included upper respiratory tract infection, diarrhea, and vomiting.
The submission is also supported by data from the INTEGUMENT-OLE open-label extension study in which patients ages 2 to 5 (n = 562) were treated for up to 52 weeks.
About ZORYVE (roflumilast) Cream
Roflumilast cream is a next generation topical PDE4 inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Roflumilast cream 0.15% (ZORYVE) is approved by the FDA for the topical treatment of mild to moderate AD in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour's Beauty and Wellness award for "Eczema Product."
INDICATIONS
ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.
ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).
The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).
The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
Please see full Prescribing Information.
About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis' dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, AD, and alopecia areata. For more information, visit or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
Forward-Looking Statements
Arcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential FDA approval of ZORYVE cream 0.05%, the potential of real-world use results of ZORYVE cream in AD in children aged 2 to 5, and the potential for ZORYVE cream to advance the standard of care in AD and other inflammatory dermatological conditions. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the "Risk Factors" section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com
Investors
Latha Vairavan, Vice President, Finance and Corporate Controller
ir@arcutis.com
- ZORYVE 乳膏 0.05% 在關鍵臨床試驗中提供了顯著的疾病清除和快速的瘙癢減輕。
- Roflumilast 乳膏耐受性良好,並且在長達 56 周的治療中顯示出良好的安全性和耐受性。
- 在美國,大約有 180萬名 2 到 5 歲的特應性皮炎 (AD) 兒童接受局部治療。
加利福尼亞州西湖村,2024 年 12 月 16 日(全球新聞網)-- Arcutis Biotherapeutics, Inc. (納斯達克: ARQT),是一家商業階段的生物製藥公司,專注於在免疫皮膚病領域開發重要創新,今天宣佈向美國食品和藥物管理局(FDA)提交了補充新藥申請(sNDA),申請ZORYVE (羅非呫) 乳膏0.05%的上市,這是一種每日一次、下一代磷酸二酯酶4(PDE4)抑制劑,用於2至5歲兒童輕度至中度特應性皮炎的局部治療。
"在爲患有特應性皮炎(AD)的幼兒選擇治療時,醫療提供者和照顧者必須考慮兒科患者的獨特因素,包括敏感肌膚,並選擇適合長期使用的藥物,適合長期皮膚病的兒童。關鍵試驗的數據表明,0.05% 的roflumilast乳膏提供了一致且快速的緩解,並且耐受性良好,"DOCS皮膚科的Rocco Serrao博士,FAAD說,INTEGUMENt-PED和INTEGUMENt-OLE的研究員。"如果獲得批准,0.05% 的roflumilast乳膏將爲這些年輕患者提供一種新的局部治療選擇,具有改善這些年輕患者護理標準的潛力,爲兒童及其家庭提供迅速緩解,以應對AD的困擾症狀。"
AD是一種慢性、遺傳易感的複發性炎症性皮膚病,在生活的各個階段都會出現。該病可能表現爲紅色、強烈瘙癢的皮疹,可能出現在身體的任何部位,並且在兒童和成人中可能表現得不同。兒科AD可能對兒童及其家庭或看護者的生活質量產生負面影響。
"家長、照顧者和醫療專業人員需要對他們的治療計劃充滿信心。我們對ZORYVE的臨床開發計劃強化了roflumilast乳膏公認的療效、安全性和耐受性特徵,該乳膏設計用於在不破壞皮膚屏障或使用敏感化賦形劑和刺激物的情況下遞送藥物。這種較低濃度的roflumilast乳膏是爲滿足AD年輕兒童的需求而特別配製的,體現了我們服務這一脆弱患者群體的承諾,"Arcutis的總裁兼首席執行官Frank Watanabe說。"如果獲得批准,我們期待能夠爲180萬名2至5歲的AD兒童及其家庭提供0.05%的ZORYVE乳膏,作爲一種新的局部療法。"
這項補充新藥申請(sNDA)得到了一項關鍵性3期試驗、一項關鍵性長期延續研究以及一項1期藥代動力學研究的積極結果的支持。INTEGUMENt-PED的對照乳膏關鍵性3期試驗招募了652名2至5歲的兒童,平均特應性皮炎(AD)體表面積(BSA)爲22%,範圍爲3%到82%。在該研究中,經過4周治療,25.4%的使用0.05% roflumilast乳膏的兒童達到了vIGA-AD成功,定義爲經過驗證的特應性皮炎全球評估(vIGA-AD)評分爲「清晰」或「幾乎清晰」且比基線改善了2個等級,而使用對照組的兒童僅爲10.7%(P<0.0001),並且顯著改善的效果在1周時便已顯現。所有的次要終點也都達成,包括在1周時的vIGA-AD成功和vIGA-AD達到「清晰」和「幾乎清晰」。此外,使用roflumilast乳膏的兒童在基線時最嚴重瘙癢數字評分(WI-NRS) ≥4(由看護者報告)的有35.3%在第4周達成WI-NRS降低四分的效果(對照組兒童的降低率爲18.0% [名義P=0.0002])。
羅非米特乳膏0.05%耐受性良好。在試驗中接受ZORYVE乳膏0.05%治療的2至5歲兒童的整體安全性剖面與成年及接受ZORYVE乳膏0.15%治療的較大兒童的良好安全性剖面一致,後者患有輕度至中度的特應性皮炎。羅非米特組中發生頻率較高的不良事件,包括上呼吸道感染、腹瀉和嘔吐,發生率超過對照組(≥2%)。
該申請還得到了INTEGUMENt-OLE開放標籤擴展研究的數據支持,該研究中2至5歲的患者(n = 562)接受了最長52周的治療。
關於ZORYVE(羅非米特)乳膏
羅非米特乳膏是一種新一代的局部PDE4抑制劑。PDE4是皮膚病學中一個既定的靶點,是一種細胞內酶,能夠增加促炎介質的產生並減少抗炎介質的產生。羅非米特乳膏0.3%(ZORYVE)已獲得FDA批准,用於6歲及以上患者的斑塊型牛皮癬的局部治療,包括皮膚皺褶部位。羅非米特乳膏0.15%(ZORYVE)已獲得FDA批准,用於6歲及以上患者輕度至中度特應性皮炎的局部治療。2024年,ZORYVE乳膏0.15%獲得了《Glamour》雜誌的美容與健康獎,榮譽稱號爲「溼疹產品」。
適應症
ZORYVE霜,0.3%,適用於6歲及以上的成人和兒童患者的斑塊型銀屑病的局部治療,包括皮膚皺褶部位。
ZORYVE霜,0.15%,適用於6歲及以上的成人和兒童患者的輕度至中度特應性皮炎的局部治療。
重要安全信息
ZORYVE禁用於中度至重度肝功能障礙的患者(Child-Pugh B或C)。
ZORYVE 0.3%乳膏用於斑塊狀銀屑病的最常見不良反應(≥1%)包括腹瀉(3.1%)、頭痛(2.4%)、失眠(1.4%)、噁心(1.2%)、塗抹部位疼痛(1.0%)、上呼吸道感染(1.0%)和尿路感染(1.0%)。
ZORYVE 0.15%乳膏用於特應性皮炎的最常見不良反應(≥1%)包括頭痛(2.9%)、噁心(1.9%)、塗抹部位疼痛(1.5%)、腹瀉(1.5%)和嘔吐(1.5%)。
請見完整信息。 處方信息.
關於Arcutis
Arcutis Biotherapeutics, Inc.(納斯達克:ARQT)是一家商業階段的醫療皮膚病公司,致力於有意義的創新,以解決生活在免疫介導的皮膚病及相關疾病中的個人的迫切需求。Arcutis專注於解決皮膚科中最持久的患者挑戰,擁有不斷增長的產品組合,包括三款FDA批准的產品,它們結合了我們獨特的皮膚科開發平台和專業知識,以建立針對生物驗證靶點的差異化治療。Arcutis的皮膚科開發平台包括一個強大的管道,具有多個針對各種炎症性皮膚病(包括頭皮和全身銀屑病、特應性皮炎和局部脫髮)的臨床項目。有關更多信息,請訪問 或關注Arcutis的 LinkedIn, 臉書, Instagram,以及 X.
前瞻性聲明
Arcutis提醒您,本新聞稿中關於非歷史事實事項的陳述爲前瞻性陳述。這些陳述基於公司當前的信念和預期。這類前瞻性陳述包括但不限於關於ZORYVE乳膏0.05%潛在FDA批准的陳述、ZORYVE乳膏在2至5歲兒童中治療特應性皮炎(AD)的實際使用結果的潛力,以及ZORYVE乳膏提高AD及其他炎症性皮膚病標準治療的潛力。這些陳述受已知和未知的重大風險、不確定性以及其他可能導致我們的實際結果、活動水平、績效或成就與這些前瞻性陳述所表達或暗示的信息有實質性不同的因素的影響。可能導致我們實際結果不同的風險和不確定性包括我們業務固有的風險、產品的報銷和獲取情況、競爭的影響以及我們在2024年2月27日向美國證券交易委員會(SEC)提交的10-K表格中討論的其他重要因素,以及之後向SEC的任何提交。您不應對本新聞稿中的任何前瞻性陳述給予過度依賴。即使新信息可用,我們也沒有義務修改或更新此處的信息以反映未來的事件或情況。所有前瞻性陳述均受到本警示性聲明的全面限制,此聲明是根據1995年《私人證券訴訟改革法》的安全港條款作出的。
聯繫方式:
媒體
企業傳訊負責人阿曼達·謝爾頓
media@arcutis.com
投資者
Latha Vairavan,財務和公司控制副總裁
ir@arcutis.com