FDA批准Ajovy（fremanezumab-vfrm）扩大适应症，这是首个用于儿童阵发性偏头痛预防的抗CGRP治疗药物FDA Approves Expanded Indication for Ajovy (fremanezumab-vfrm), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine

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08/07

PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U...

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(NYSE and TASE: TEVA), announced today that the U...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025080710331794d4a3c2&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025080710331794d4a3c2&s=b","article_id":"2557580919","we_media_id":null,"thumbnails":[],"rights":{"source":"tencent","url":"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025080710331794d4a3c2&s=b","rn_cache_url":null,"customStyle":"body{padding-top:10px;}#news_title{font-weight:bold;#titleStyle#;}#news_description span{font-size:12px;#descriptionStyle#;}.footer-note{#statement#}","selectors":".mod-LoadTzbdNews, body","filters":".relate-stock, .hot-list, .recom-box, .wx-sou","directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2557580919","pubTimestamp":1754533920,"columns":[],"sourceInfo":{"source_id":"tencent","name":"腾讯"},"weMediaInfo":null,"summary":"通过此项批准，Ajovy成为首个且唯一用于预防性治疗儿科患者偶发性偏头痛和成人偏头痛的降钙素基因相关肽拮抗剂，标志着在扩大偏头痛患者预防性治疗选择方面取得了重要的进展。Ajovy每月注射一次，可在诊所或家中使用，提供了一种旨在支持依从性并减轻家庭治疗负担的治疗选择。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK4588":"碎股","TEVA":"梯瓦制药","BK4585":"ETF&股票定投概念","BK4557":"大麻股","BK4007":"制药","BK4596":"哈里斯概念","BK4559":"巴菲特持仓","BK4584":"避孕概念","BK4566":"资本集团"},"translate_title":"FDA approves expanded indications for Ajovy (fremanezumab-vfrm), the first anti-CGRP treatment for the prevention of paroxysmal migraine in children FDA Approves Expanded Indication for Ajovy (fremanezumab-vfrm), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"TEVA":0.9},"content_text":"PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U.S. Food and Drug Administration (FDA) has approved帕西帕尼，新泽西州，特拉维夫，以色列，2025年8月6日（环球新闻社）-- 梯瓦制药公司，梯瓦制药工业有限公司（纽约证券交易所和特拉维夫证券交易所代码：TEVA）的美国分公司，今天宣布美国食品药品监督管理局（FDA）已批准Ajovy艾joyfor the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. With this approval, Ajovy becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults, marking a meaningful advancement in expanding preventive treatment options for those living with migraine..用于预防性治疗体重45公斤（99磅）及以上的6至17岁儿童和青少年的偶发性偏头痛。通过此项批准，Ajovy成为首个且唯一用于预防性治疗儿科患者偶发性偏头痛和成人偏头痛的降钙素基因相关肽（CGRP）拮抗剂，标志着在扩大偏头痛患者预防性治疗选择方面取得了重要的进展。Preventative treatment can help reduce the frequency of migraine attacks, helping children and adolescents to better manage the condition day-to-day. Ajovy is administered once a month and available for in-office or at home use, offering a treatment option that is intended to support adherence and reduce treatment burden for families..预防性治疗可以帮助减少偏头痛发作的频率，帮助儿童和青少年更好地日常管理病情。Ajovy每月注射一次，可在诊所或家中使用，提供了一种旨在支持依从性并减轻家庭治疗负担的治疗选择。11“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” said Chris Fox, Executive Vice President, U.S. Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva. “With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.”.“偏头痛是一种常见但隐形的疾病，可能严重扰乱儿童和青少年的日常生活，常常使他们被忽视和误解，”梯瓦公司美国商业及创新特许经营负责人兼全球营销业务主管、执行副总裁克里斯·福克斯表示。“随着此次FDA的批准，Ajovy现在为年轻患者提供了一种新的治疗选择，填补了长期以来的护理空白，并为那些应对这种疾病挑战的家庭提供了更多支持。”1 in 10 children and adolescents in the U.S. suffer from migraine, one of the most common and disabling neurological conditions.美国每10名儿童和青少年中就有1人患有偏头痛，这是最常见和致残的神经系统疾病之一。33Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.尽管小儿偏头痛普遍存在，但往往未能得到充分认识和治疗，导致缺课、学业困难和社交活动受干扰。44'Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being,' said Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute. “Having an FDA-approved treatment like Ajovy offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”.“儿童偏头痛是一种复杂的疾病，可能显著影响孩子的日常生活，从学业表现到情绪健康，”DENT神经科学研究所的儿科神经学家Jennifer McVige博士表示。“拥有像Ajovy这样获得FDA批准的治疗方案提供了一个重要的选择，为偶发性偏头痛提供了针对性的预防治疗方法，可以帮助减少年轻患者的发作频率，并帮助临床医生管理这一常被忽视的疾病。”Building on its established success in adult patients since its U.S. approval in 2018, this expanded indication strengthens Teva’s commitment to broadening access to neuroscience therapies across age groups.自2018年在美国获批以来，该药物在成年患者中已取得显著成功，此次适应症的扩展进一步彰显了梯瓦致力于扩大各年龄群体对神经科学疗法的可及性。22Ajovy continues to demonstrate efficacy in addressing the underlying biology of migraine and now provides a treatment pathway for a patient population with historically limited preventive options.Ajovy继续证明其在解决偏头痛生物学基础方面的有效性，并为以往预防选择有限的患者群体提供了一种治疗途径。About Migraine关于偏头痛Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.偏头痛发作会导致严重的疼痛、恶心、呕吐以及对光和声音的敏感，从而严重影响完成日常任务的能力。55Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.偏头痛可导致儿童和青少年出现显著的残疾，导致缺课、教育表现受损以及错过社交活动。33About Ajovy关于AjovyAjovy is indicated for preventive treatment of migraine in adults and episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. Ajovy is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe.Ajovy 适用于成人偏头痛的预防性治疗，以及体重在45公斤（99磅）及以上、6-17岁的儿童和青少年患者的偶发性偏头痛。Ajovy 提供225毫克/1.5毫升单剂量注射，采用预填充自动注射器或预填充注射器。Ajovy can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment..Ajovy 可由医疗专业人员施用，也可由患者或护理人员在家中施用。开始治疗无需起始剂量。INDICATION AND USAGE适应症和用法Ajovy is indicated for:Ajovy适用于：IMPORTANT SAFETY INFORMATION重要安全信息Contraindications:禁忌症：Ajovy is contraindicated in patients with serious hypersensitivity toAjovy禁用于对本品严重过敏的患者。fremanezumabfremanezumab（弗雷马那单抗）-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.对活性物质或任何辅料过敏者禁用。不良反应包括过敏性休克和血管性水肿。Hypersensitivity Reactions:超敏反应：Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with Ajovy in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration.在临床试验中，使用Ajovy报告了包括皮疹、瘙痒、药物过敏和荨麻疹在内的超敏反应。大多数反应为轻到中度，但有些导致停药或需要皮质类固醇治疗。大多数反应在给药后数小时至一个月内报告。Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing Ajovy and institute appropriate therapy.在上市后阶段已报告出现过敏反应和血管性水肿的病例。如果发生超敏反应，应考虑停用Ajovy并采取适当的治疗措施。.。Hypertension:高血压：Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Ajovy, in the postmarketing setting.在上市后使用CGRP拮抗剂（包括Ajovy）的报告中，出现了高血压的发展和原有高血压恶化的现象。Monitor patients treated with Ajovy for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of Ajovy is warranted监测接受Ajovy治疗的患者是否出现新发高血压或原有高血压恶化，并考虑是否需要停用Ajovy。.。Raynaud’s Phenomenon雷诺现象: Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Ajovy. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain..在使用CGRP拮抗剂（包括Ajovy）后，上市后的环境中已报告出现雷诺现象的发展以及先前存在的雷诺现象的复发或恶化。许多报告的病例出现了严重后果，包括住院和残疾，通常与剧烈疼痛相关。Ajovy should be discontinued if signs or symptoms of Raynaud’s phenomenon develop. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.如果出现雷诺现象的体征或症状，应停止使用Ajovy。有雷诺现象病史的患者应被监测，并被告知症状可能恶化或复发的情况。Adverse Reactions:不良反应：The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.临床试验中最常见的不良反应（≥5%且高于安慰剂）是注射部位反应。About Teva关于TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future.Teva制药工业有限公司（纽约证券交易所和特拉维夫证券交易所代码：TEVA）是一家领先的创新型生物制药公司，依托世界级的仿制药业务。在120多年的时间里，Teva的承诺从未动摇。从在神经科学和免疫学领域的创新，到在全球范围内提供复杂的仿制药、生物类似药和药店品牌，Teva始终致力于满足患者的需求，无论是现在还是未来。At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com..在特瓦，我们全力以赴追求更好的健康。欲了解更多信息，请访问 www.tevapharm.com。Cautionary Note Regarding Forward-Looking Statements关于前瞻性陈述的注意事项This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements.本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性陈述，这些陈述基于管理层当前的信念和期望，并受到大量已知和未知风险及不确定因素的影响，这些风险和不确定因素可能导致我们未来的业绩、表现或成就与此类前瞻性陈述中明示或暗示的内容存在重大差异。You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance.您可以根据诸如“应该”、“预期”、“预计”、“估计”、“目标”、“可能”、“预测”、“指引”、“打算”、“计划”、“相信”等词语及其在任何关于未来运营或财务表现的讨论中具有相似含义和表达的术语来识别这些前瞻性陈述。Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize Ajovy (fremanezumab) for the prevention of episodic migraine in children and adolescents; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-loo.可能导致或促成此类差异的重要因素包括与以下方面相关的风险：我们成功开发和商业化Ajovy（fremanezumab）用于预防儿童和青少年偶发性偏头痛的能力；我们在市场中成功竞争的能力，包括我们开发和商业化其他医药产品的能力；我们成功执行“转型增长”战略的能力，包括扩展我们的创新药和生物类似药的产品线，并通过自主发展或业务拓展实现创新药物和生物类似药组合的盈利商业化；以及本新闻稿、截至2025年第二季度的10-Q表季度报告和截至2024年12月31日年度的10-K表年度报告中讨论的其他因素，特别是标题为“风险因素”的部分。前瞻性声明仅在其发布之日有效，我们不承担更新或修订任何前瞻性声明的义务。Source: Teva Pharmaceuticals来源：梯瓦制药公司Ajovy (fremanezumab-vfrm) FDA Approval HistoryAjovy（fremanezumab-vfrm）FDA批准历史Whatever your topic of interest,无论你感兴趣的话题是什么，subscribe to our newsletters订阅我们的新闻通讯to get the best of Drugs.com in your inbox.获取 Drugs.com 的最新资讯到您的邮箱。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"}}}