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TITUSVILLE, N.J., July 28, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of EDURANT® (rilpivirine) to include the treatment of HIV-1 infection in children weighing 10 kg or more. A parallel Marketing Authorization application has also been submitted to the European Medicines Agency (EMA) in support of a type II variation and line extension for expanded pediatric use in Europe. These applications reflect Janssen’s longstanding commitment to address the needs of adults, adolescents and children affected by the global HIV epidemic.If the new applications are approved, EDURANT®, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, could be administered to younger pediatric patients via standard 25 mg tablets or new 2.5 mg tablets for oral dispersion that were developed to aid administration and weight-adjusted dosing for children. “We’ve been working to fight HIV for decades and are proud to have helped bring forward nine medicines for people living with HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. “These filings are the latest example of our longstanding work to make different treatment options available to meet the diverse needs of people living with HIV.”The expanded pediatric applications are supported by data from the Phase 2 PAINT (NCT00799864) and PICTURE (NCT04012931) studies, which showed that EDURANT®, in combination with other antiretroviral therapies, effectively maintains or suppresses the virus in treatment-experienced and treatment-naive pediatric patients, respectively. Given these data, Janssen is seeking an expanded indication to allow use in treatment-naïve children (with HIV-1 RNA <100,000 copies/mL) and treatment-experienced virologically suppressed children (with HIV-1 RNA <50 copies/mL) weighing 10 kg or more.The expansion of the EDURANT® indication would mark the latest step forward in Janssen’s efforts to make its HIV medicines available to young people living with HIV. In 2022, the FDA approved the world’s first long-acting injectable HIV-1 treatment option for adolescents 12 years of age and older. This regimen consists of Janssen’s long-acting rilpivirine and ViiV Healthcare’s long-acting cabotegravir and requires as few as six treatments per year.Johnson & Johnson’s Commitment to HIVIn addition to driving innovation in HIV care, Johnson & Johnson also works with vulnerable communities on the global frontlines of the HIV epidemic, and has supported collaborative initiatives like Positively Fearless, the DREAMS Partnership and the MenStar Coalition. We also support the New Horizons Collaborative, which is working to address the unmet needs of HIV treatment-experienced children, adolescents and young adults in sub-Saharan Africa.To learn more about Johnson & Johnson’s commitment to combating HIV, please visit jnj.com/HIV.About EDURANT®EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. Limitations of Use:EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.Please see full Prescribing Information for important safety information.Important Safety InformationWho should not take EDURANT®?Do not take EDURANT® if you also take:What should I tell my healthcare provider before taking EDURANT®?Before taking EDURANT®, tell your healthcare provider about all your medical conditions, including if you:Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.Some medicines interact with EDURANT®. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with EDURANT®.Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take EDURANT® with other medicines.How should I take EDURANT®?What are the possible side effects of EDURANT®?EDURANT® can cause serious side effects including:Stop taking EDURANT® and get medical help right away if you develop a rash with any of the following signs or symptoms:Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT®. Liver problems have also happened during treatment with EDURANT® in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment with EDURANT®. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems:Depression or mood changes. Tell your healthcare provider right away if you have any of the following symptoms:Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.The most common side effects of EDURANT® include depression, headache, trouble sleeping (insomnia), and rash.This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away.You are encouraged to report side effects of prescription drugs to the FDA. www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).Please read the full Product Information for EDURANT® and discuss any questions you have with your healthcare provider.About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Sciences Ireland Unlimited Company and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and other treatments for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland Unlimited Company, Janssen Research & Development, LLC, the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.###© Janssen Therapeutics, Division of Janssen Products, LP

Flatiron Health在肿瘤领域建立了EHR（Electronic Health Records,电子健康档案），2018年被罗氏以19亿美元的价格收购。美国初创公司Vital Software也为医院急症科（ED，Emergency Department）搭建一个类似的智能数字平台。Vital是一款利用AI和NLP（自然语言处理，Natural Language Processing）的现代化消费级软件。目前，已经部署在美国100多家医院和31个卫生系统中。Vital在2019年获得了Flatiron Health的创始人Nat Turner和Zach Weinberg以及其他投资者共计520万美元的种子轮投资。创始人Aaron Patzer自己也投资了100万美元。近日，Vital宣布其B轮融资共获2470万美元，融资总额超过4000万美元，由Transformation Capital领投，Threshold Ventures和创始人Aaron Patzer跟投。 Vital融资历史动脉网整理制作   数字平台连续创业者，入选《财富》四十强Vital Software的联合创始人兼CEO Aaron Patzer是位80后的互联网创业者，拥有普林斯顿大学的电子工程硕士学位。他的职业生涯始于1998-2000年的互联网繁荣时期，期间曾在多家互联网初创企业担任工程师。Aaron Patzer图源：Twitter.com2006年Patzer开始了他第一次创业：Mint.com。Mint是一款在线的个人理财助手，用户可以从该平台看到个人的全部账户信息，并实现完全自动记账、信用卡自动还款等服务。2008年，Patzer被美国商业杂志《公司》（Inc.）评为“Top 30 Under 30”的精英。2009年又被《财富》（Fortune）杂志评为“40 under 40”的商业精英。Patzer在2013年推出了Fountain.com。Fountain是一款在线的微型咨询市场，用户通过“1 VS 1”的聊天或视频通话获得来自各行各业专业人士的建议，包括兽医、律师等领域的技术专家。2015年，Patzer以未披露的价格将Fountain出售给了家庭服务平台Porch后便离开了硅谷，前往新西兰。此次Patzer计划为急诊室开发一款现代化的人工智能软件，用以提高患者服务满意度、优化急诊室和住院患者流量以及对后续患者护理计划的延续性。Vital的灵感之初是Patzer为了帮助他的姐姐，一位做移植研究的教授开发关于肾移植的机器学习算法，这被他的姐夫美国埃默里大学（Emory University）急诊医学博士Justin Schrager发现。Schrager想知道这款机器学习算法是否能运用到急诊领域，帮助优化急症室的EHR系统，进而解决忙碌、混乱的急诊现状。事实证明，这个想法是可行的。2017年，Patzer和姐夫Schrager经过了两年的同行评审（Peer Review）的学术研究和技术研发，共同创办了Vital Software。与EHR无缝集成，两大AI平台为急诊医生和患者赋能2009年，美国总统签署了HITECH（经济和临床健康信息技术法案），该法案投入了数百亿美元用于帮助医院安装建立EHR等平台。但从一开始，医院安装EHR的初衷就不是为了改善患者的体验，并且随着人口数量的增长以及新冠大流行的偶发，使原本就不堪重负的急症系统雪上加霜。由于缺乏新技术，患者和医生都受到了影响，导致急诊室患者的等待时间增加。美国医学学会（American Medical Association）的一项研究表明，医生每在病房与患者相处一个小时，他们就要在办公室花近两个小时填写EHR和进行其他文字工作。为了替代医院Windows 98风格的软件，Vital为ED提供了一款面向患者和临床医生的现代化AI软件作为解决方案。它的设计并不是为了取代现有EHR，而是帮助EHR。Vita可以轻松接入任何卫生系统的EHR，并在几天或几周内就投入运营。American Medical Software与Vital图源：AMS与Vital官网Vital是一款能提高ED的生产力，并改善患者健康状况的消费者友好软件。目前，针对服务对象的不同，分别为ED、住院患者以及医院各提供了一套解决方案。● ERAdvisor：预测急诊室各环节等候时长，平均准确率达94%患者来到ED就诊时简单来说通常经历六个环节：登记，分诊，床位分配，等待医护人员，等待临床决策以及入院或出院。ED本该是为急重病人诊治的地方，但现在却呈现“急诊不急”的现象。美国一些急诊室的患者等待时间可达50小时，这引起了患者的不满并造成了治疗的延误。患者急诊就诊流程Vital的旗舰产品ERAdvisor就是为了解决“急诊不急”这个难题。ERAdvisor能为患者提供ED的最新实时信息。Vital通过构建数字模型，预测各个步骤的等待时长，利用AI、机器学习技术Tecton、NLP处理信息，最后结合UI设计输出为个性化、易于理解的数据和图像。对比ERAdvisor预测的等待时间以及实际患者在该流程的等待时间，ERAdvisor的平均预测准确率为94%。图一：患者自动收到就诊信息的文本邀请，无需注册或下载即可访问；图二：当日该急诊环节等待时长、流程信息及全天时长预测；图三：急症流程进展，和亲友共享急诊信息图源：Vital官网ERAdvisor搭载在web平台上，亲友可以实时和患者以及护理团队进行沟通。急诊后的护理提醒也可以以短信的形式直接发送到患者手机，医生也可以在平台获取不同患者的后续护理信息。这种随访的及时性增加了ED运营及管理效率。● CareAdvisor：串联入院到出院的全流程，实现患者住院的信息透明性CareAdvisor是一个面向患者、临床医生和医院工作人员的移动端住院平台。通过接入医院的EHR，患者、临床医生和家属可以通过CareAdvisor现代化的UI界面获得所需的信息。图一：患者EHR信息；AI预测患者健康信息及出院安排进展；图二：患者检查情况及报告解读；图三：患者可以查看并填写每日每小时的身体情况图源：Vital官网患者就诊时无需下载app，通过安全链接填写手机号注册登记。CareAdvisor接入EHR后可将其数据进行AI预测分析，帮助患者了解病情变化，设定治疗目标，并且可以代替护士日常指导住院病人用药和护理，减少医护人员工作量，缩短患者住院时长。作为一款消费者友好软件，通过回答对患者来说最重要的问题，CareAdvisor让患者自发地参与到医护人员的治疗和护理中。住院患者可以通过CareAdvisor查看检查报告，系统通过AI分析给出预测结果及并推荐视频，帮助患者个人了解如何检测及报告数据。CareAdvisor为住院患者提供了个性化的护理体验。患者的每时情况表除了患者和医生可以随时访问，患者也可以和家属分享链接，共同管理每日健康情况。住院患者还可以在CareAdvisor获得订餐、病房清洁等服务，还可以为每一项服务在线打分。CareAdvisor的服务将一直延续到患者的出院小结。ERAdvisor和CareAdvisor二者结合可以大大提高医生沟通、治疗及管理效率。 医护人员移动端服务页面图源：Vital官网 获HITRUST r2认证，双重防护保障各方数据安全Vital可与任何一款急症科的EHR集成，如Epic、Cerner、Meditech等，但医院固有的信息内网在接入在云端运行处理的Vital时，应如何防止任一环节发生信息泄露呢？Vital对此设立了两重技术的安全防护。首先，Vital采用HL7（Health Level 7）的标准框架FHIR（Fast Healthcare Interoperability Resources，快捷式医疗保健互操作性资源）接口传递重要信息。其次，无需下载应用或是注册，Vital采用LDAP、SAML、OAuth的单点登录（single sign-on，SSO）协议，医生或患者只需在Vital中登录一次，就能在其他子应用系统中认证其身份，而免去重复登录增加账户信息泄露的风险，增强用户安全感体验。这两层安全防护技术可以保证急症室的信息数据符合HIPAA法案。目前Vital已成功完成美国注册会计师协会（AICPA）的SOC 2（Service Organization Control）报告中的2类审核，该报告主要是对Vital安全性、机密性的审核。Vital还获得了HITRUST（健康信息信任联盟，Health Information Trust Alliance）r2的认证。HITRUST r2的验证被认为是评估信息安全的黄金标准。相比于个人财务管理系统Mint，Vital所面对的急症室是一个受到政府、管理机构以及患者高度监管的领域。但Patzer设计Vital和Mint的初衷是相似的，都是以消费者为中心，让患者了解、参与、负责他们的急诊护理过程，并使用AI技术来改善患者体验和临床护理水平，实现信息共享的透明性、安全性。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台