- 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% 在关键临床试验中提供了显著的疾病清除和快速的瘙痒减轻。
- Roflumilast 乳膏耐受性良好，并且在长达 56 周的治疗中显示出良好的安全性和耐受性。
- 在美国，大约有 180万名 2 到 5 岁的特应性皮炎 (AD) 儿童接受局部治疗。
加利福尼亚州西湖村，2024 年 12 月 16 日（全球新闻网）-- Arcutis Biotherapeutics, Inc. (纳斯达克: ARQT)，是一家商业阶段的生物制药公司，专注于在免疫皮肤病领域开发重要创新，今天宣布向美国食品和药物管理局(FDA)提交了补充新药申请(sNDA)，申请ZORYVE (罗非呫) 乳膏0.05%的上市，这是一种每日一次、下一代磷酸二酯酶4(PDE4)抑制剂，用于2至5岁儿童轻度至中度特应性皮炎的局部治疗。
"在为患有特应性皮炎（AD）的幼儿选择治疗时，医疗提供者和照顾者必须考虑儿科患者的独特因素，包括敏感肌肤，并选择适合长期使用的药物，适合长期皮肤病的儿童。关键试验的数据表明，0.05% 的roflumilast乳膏提供了一致且快速的缓解，并且耐受性良好，"DOCS皮肤科的Rocco Serrao博士，FAAD说，INTEGUMENt-PED和INTEGUMENt-OLE的研究员。"如果获得批准，0.05% 的roflumilast乳膏将为这些年轻患者提供一种新的局部治疗选择，具有改善这些年轻患者护理标准的潜力，为儿童及其家庭提供迅速缓解，以应对AD的困扰症状。"
AD是一种慢性、遗传易感的复发性炎症性皮肤病，在生活的各个阶段都会出现。该病可能表现为红色、强烈瘙痒的皮疹，可能出现在身体的任何部位，并且在儿童和成人中可能表现得不同。儿科AD可能对儿童及其家庭或看护者的生活质量产生负面影响。
"家长、照顾者和医疗专业人员需要对他们的治疗计划充满信心。我们对ZORYVE的临床开发计划强化了roflumilast乳膏公认的疗效、安全性和耐受性特征，该乳膏设计用于在不破坏皮肤屏障或使用敏感化赋形剂和刺激物的情况下递送药物。这种较低浓度的roflumilast乳膏是为满足AD年轻儿童的需求而特别配制的，体现了我们服务这一脆弱患者群体的承诺，"Arcutis的总裁兼首席执行官Frank Watanabe说。"如果获得批准，我们期待能够为180万名2至5岁的AD儿童及其家庭提供0.05%的ZORYVE乳膏，作为一种新的局部疗法。"
这项补充新药申请（sNDA）得到了一项关键性3期试验、一项关键性长期延续研究以及一项1期药代动力学研究的积极结果的支持。INTEGUMENt-PED的对照乳膏关键性3期试验招募了652名2至5岁的儿童，平均特应性皮炎（AD）体表面积（BSA）为22%，范围为3%到82%。在该研究中，经过4周治疗，25.4%的使用0.05% roflumilast乳膏的儿童达到了vIGA-AD成功，定义为经过验证的特应性皮炎全球评估（vIGA-AD）评分为“清晰”或“几乎清晰”且比基线改善了2个等级，而使用对照组的儿童仅为10.7%（P<0.0001），并且显著改善的效果在1周时便已显现。所有的次要终点也都达成，包括在1周时的vIGA-AD成功和vIGA-AD达到“清晰”和“几乎清晰”。此外，使用roflumilast乳膏的儿童在基线时最严重瘙痒数字评分（WI-NRS） ≥4（由看护者报告）的有35.3%在第4周达成WI-NRS降低四分的效果（对照组儿童的降低率为18.0% [名义P=0.0002]）。
罗非米特乳膏0.05%耐受性良好。在试验中接受ZORYVE乳膏0.05%治疗的2至5岁儿童的整体安全性剖面与成年及接受ZORYVE乳膏0.15%治疗的较大儿童的良好安全性剖面一致，后者患有轻度至中度的特应性皮炎。罗非米特组中发生频率较高的不良事件，包括上呼吸道感染、腹泻和呕吐，发生率超过对照组（≥2%）。
该申请还得到了INTEGUMENt-OLE开放标签扩展研究的数据支持，该研究中2至5岁的患者（n = 562）接受了最长52周的治疗。
关于ZORYVE（罗非米特）乳膏
罗非米特乳膏是一种新一代的局部PDE4抑制剂。PDE4是皮肤病学中一个既定的靶点，是一种细胞内酶，能够增加促炎介质的产生并减少抗炎介质的产生。罗非米特乳膏0.3%（ZORYVE）已获得FDA批准，用于6岁及以上患者的斑块型牛皮癣的局部治疗，包括皮肤皱褶部位。罗非米特乳膏0.15%（ZORYVE）已获得FDA批准，用于6岁及以上患者轻度至中度特应性皮炎的局部治疗。2024年，ZORYVE乳膏0.15%获得了《Glamour》杂志的美容与健康奖，荣誉称号为“湿疹产品”。
适应症
ZORYVE霜，0.3%，适用于6岁及以上的成人和儿童患者的斑块型银屑病的局部治疗，包括皮肤皱褶部位。
ZORYVE霜，0.15%，适用于6岁及以上的成人和儿童患者的轻度至中度特应性皮炎的局部治疗。
重要安全信息
ZORYVE禁用于中度至重度肝功能障碍的患者（Child-Pugh B或C）。
ZORYVE 0.3%乳膏用于斑块状银屑病的最常见不良反应(≥1%)包括腹泻(3.1%)、头痛(2.4%)、失眠(1.4%)、恶心(1.2%)、涂抹部位疼痛(1.0%)、上呼吸道感染(1.0%)和尿路感染(1.0%)。
ZORYVE 0.15%乳膏用于特应性皮炎的最常见不良反应(≥1%)包括头痛(2.9%)、恶心(1.9%)、涂抹部位疼痛(1.5%)、腹泻(1.5%)和呕吐(1.5%)。
请见完整信息。 处方信息.
关于Arcutis
Arcutis Biotherapeutics, Inc.（纳斯达克：ARQT）是一家商业阶段的医疗皮肤病公司，致力于有意义的创新，以解决生活在免疫介导的皮肤病及相关疾病中的个人的迫切需求。Arcutis专注于解决皮肤科中最持久的患者挑战，拥有不断增长的产品组合，包括三款FDA批准的产品，它们结合了我们独特的皮肤科开发平台和专业知识，以建立针对生物验证靶点的差异化治疗。Arcutis的皮肤科开发平台包括一个强大的管道，具有多个针对各种炎症性皮肤病（包括头皮和全身银屑病、特应性皮炎和局部脱发）的临床项目。有关更多信息，请访问 或关注Arcutis的 LinkedIn, 脸书, Instagram，以及 X.
前瞻性声明
Arcutis提醒您，本新闻稿中关于非历史事实事项的陈述为前瞻性陈述。这些陈述基于公司当前的信念和预期。这类前瞻性陈述包括但不限于关于ZORYVE乳膏0.05%潜在FDA批准的陈述、ZORYVE乳膏在2至5岁儿童中治疗特应性皮炎（AD）的实际使用结果的潜力，以及ZORYVE乳膏提高AD及其他炎症性皮肤病标准治疗的潜力。这些陈述受已知和未知的重大风险、不确定性以及其他可能导致我们的实际结果、活动水平、绩效或成就与这些前瞻性陈述所表达或暗示的信息有实质性不同的因素的影响。可能导致我们实际结果不同的风险和不确定性包括我们业务固有的风险、产品的报销和获取情况、竞争的影响以及我们在2024年2月27日向美国证券交易委员会（SEC）提交的10-K表格中讨论的其他重要因素，以及之后向SEC的任何提交。您不应对本新闻稿中的任何前瞻性陈述给予过度依赖。即使新信息可用，我们也没有义务修改或更新此处的信息以反映未来的事件或情况。所有前瞻性陈述均受到本警示性声明的全面限制，此声明是根据1995年《私人证券诉讼改革法》的安全港条款作出的。
联系方式：
媒体
企业传讯负责人阿曼达·谢尔顿
media@arcutis.com
投资者
Latha Vairavan，财务和公司控制副总裁
ir@arcutis.com
