Roflumilast

近日，华东医药股份有限公司（以下简称“公司”）全资子公司杭州中美华东制药有限公司（以下简称“中美华东”）开展的评价0.15%罗氟司特乳膏（ZORYVE®）在轻中度特应性皮炎患者中有效性和安全性的多中心、随机、双盲、赋形剂对照的Ⅲ期桥接研究在上海复旦大学附属华山医院完成首例受试者入组及给药；一项多中心、随机、双盲、赋形剂对照的评价0.3%罗氟司特乳膏（ZORYVE®）治疗中国斑块状银屑病的有效性和安全性的Ⅲ期临床研究在北京大学人民医院完成首例受试者入组及给药。 罗氟司特是一种磷酸二酯酶-4（PDE4）抑制剂，可增加促炎介质的生成并减少抗炎介质的生成，抑制PDE4可减轻炎症反应。罗氟司特乳膏是中美华东与美国纳斯达克上市公司Arcutis Biotherapeutics, Inc.（NASDAQ: ARQT）（以下简称“Arcutis”）于2023年8月签署合作协议引进的创新皮肤外用制剂产品，中美华东拥有该产品在大中华区及东南亚的独家许可。0.3%罗氟司特乳膏（ZORYVE®）于2022年7月获得美国FDA批准，用于治疗12岁及以上患者的斑块状银屑病，2023年4月在加拿大获批相同适应症，2023年10月在美国获批斑块状银屑病适应症扩展人群至6-11岁儿科人群；0.15%罗氟司特乳膏（ZORYVE®）于2024年7月获得美国FDA批准，用于治疗6岁及以上患者的轻度至中度特应性皮炎。 在银屑病治疗领域，公司目前已布局生物制剂乌司奴单抗注射液、口服小分子药物环孢素软胶囊、单方外用制剂ZORYVE®乳膏剂和泡沫剂以及复方外用制剂Wynzora®乳膏，形成了多靶点、多作用机制的银屑病产品组合，可实现全周期全人群覆盖。 其中，公司乌司奴单抗注射液（赛乐信®）（研发代码：HDM3001/QX001S）的上市许可申请在2024年10月获得批准，用于治疗成年中重度斑块状银屑病，为国产首家，儿童斑块状银屑病的补充申请于2024年12月获得受理。 本次0.15%罗氟司特乳膏和0.3%罗氟司特乳膏两项Ⅲ期临床试验均完成了首例受试者入组，是产品研发进程中的重要里程碑，将进一步提高公司在自身免疫性及炎症性皮肤病领域的核心竞争力。公司后续将继续全力推进该款产品的临床开发及注册工作，争取为中国银屑病和特应性皮炎临床患者提供更多的治疗选择。 声明 1、本新闻旨在分享公司（或合作伙伴）研发工作的前沿进展资讯，非广告用途，相关信息并非针对患者，仅供医疗卫生专业人士参考使用； 2、本新闻稿中内容不涉及对任何药品和/或适应症作推荐； 3、本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 4、截止本文发布，0.15%罗氟司特乳膏（ZORYVE®）与0.3%罗氟司特乳膏（ZORYVE®）尚未被国家药品监督管理局批准上市； 5、本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

ZORYVE cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trialsRoflumilast cream was well tolerated and demonstrated a favorable safety and tolerability profile for up to 56 weeks of treatmentApproximately 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) CreamRoflumilast 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.” INDICATIONSZORYVE 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 INFORMATIONZORYVE 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 ArcutisArcutis 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 www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking StatementsArcutis 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:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Corporate Controllerir@arcutis.com