FDA批准Ajovy（fremanezumab-vfrm）擴大適應症，這是首個用於兒童陣發性偏頭痛預防的抗CGRP治療藥物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\">網頁鏈接</a>\n\n</div>\n\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2025080710331794d4a3c2&s=b\">動脈網</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4566","symbol_name":"資本集團","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":"通過此項批准，Ajovy成為首個且唯一用於預防性治療兒科患者偶發性偏頭痛和成人偏頭痛的降鈣素基因相關肽拮抗劑，標誌着在擴大偏頭痛患者預防性治療選擇方面取得了重要的進展。Ajovy每月注射一次，可在診所或家中使用，提供了一種旨在支持依從性並減輕家庭治療負擔的治療選擇。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"BK4566":"资本集团","BK4588":"碎股","BK4584":"避孕概念","BK4585":"ETF&股票定投概念","BK4557":"大麻股","BK4596":"哈里斯概念","BK4559":"巴菲特持仓","TEVA":"梯瓦制药","BK4007":"制药"},"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，新澤西州，特拉維夫，以色列，2025年8月6日（環球新聞社）-- 梯瓦製藥公司，梯瓦製藥工業有限公司（紐約證券交易所和特拉維夫證券交易所代碼：TEVA）的美國分公司，今天宣佈美國食品藥品監督管理局（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..用於預防性治療體重45公斤（99磅）及以上的6至17歲兒童和青少年的偶發性偏頭痛。通過此項批准，Ajovy成為首個且唯一用於預防性治療兒科患者偶發性偏頭痛和成人偏頭痛的降鈣素基因相關肽（CGRP）拮抗劑，標誌着在擴大偏頭痛患者預防性治療選擇方面取得了重要的進展。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..預防性治療可以幫助減少偏頭痛發作的頻率，幫助兒童和青少年更好地日常管理病情。Ajovy每月注射一次，可在診所或家中使用，提供了一種旨在支持依從性並減輕家庭治療負擔的治療選擇。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.”.“偏頭痛是一種常見但隱形的疾病，可能嚴重擾亂兒童和青少年的日常生活，常常使他們被忽視和誤解，”梯瓦公司美國商業及創新特許經營負責人兼全球營銷業務主管、執行副總裁克里斯·福克斯表示。“隨着此次FDA的批准，Ajovy現在為年輕患者提供了一種新的治療選擇，填補了長期以來的護理空白，併為那些應對這種疾病挑戰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.美國每10名兒童和青少年中就有1人患有偏頭痛，這是最常見和致殘的神經系統疾病之一。33Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.儘管小兒偏頭痛普遍存在，但往往未能得到充分認識和治療，導致缺課、學業困難和社交活動受干擾。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.”.“兒童偏頭痛是一種複雜的疾病，可能顯著影響孩子的日常生活，從學業表現到情緒健康，”DENT神經科學研究所的兒科神經學家Jennifer McVige博士表示。“擁有像Ajovy這樣獲得FDA批准的治療方案提供了一個重要的選擇，為偶發性偏頭痛提供了針對性的預防治療方法，可以幫助減少年輕患者的發作頻率，並幫助臨牀醫生管理這一常被忽視的疾病。”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年在美國獲批以來，該藥物在成年患者中已取得顯著成功，此次適應症的擴展進一步彰顯了梯瓦致力於擴大各年齡羣體對神經科學療法的可及性。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繼續證明其在解決偏頭痛生物學基礎方面的有效性，併為以往預防選擇有限的患者羣體提供了一種治療途徑。About Migraine關於偏頭痛Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.偏頭痛發作會導致嚴重的疼痛、噁心、嘔吐以及對光和聲音的敏感，從而嚴重影響完成日常任務的能力。55Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.偏頭痛可導致兒童和青少年出現顯著的殘疾，導致缺課、教育表現受損以及錯過社交活動。33About Ajovy關於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 適用於成人偏頭痛的預防性治療，以及體重在45公斤（99磅）及以上、6-17歲的兒童和青少年患者的偶發性偏頭痛。Ajovy 提供225毫克/1.5毫升單劑量注射，採用預填充自動注射器或預填充注射器。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 可由醫療專業人員施用，也可由患者或護理人員在家中施用。開始治療無需起始劑量。INDICATION AND USAGE適應症和用法Ajovy is indicated for:Ajovy適用於：IMPORTANT SAFETY INFORMATION重要安全信息Contraindications:禁忌症：Ajovy is contraindicated in patients with serious hypersensitivity toAjovy禁用於對本品嚴重過敏的患者。fremanezumabfremanezumab（弗雷馬那單抗）-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.對活性物質或任何輔料過敏者禁用。不良反應包括過敏性休克和血管性水腫。Hypersensitivity Reactions:超敏反應：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.在臨牀試驗中，使用Ajovy報告了包括皮疹、瘙癢、藥物過敏和蕁麻疹在內的超敏反應。大多數反應為輕到中度，但有些導致停藥或需要皮質類固醇治療。大多數反應在給藥後數小時至一個月內報告。Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing Ajovy and institute appropriate therapy.在上市後階段已報告出現過敏反應和血管性水腫的病例。如果發生超敏反應，應考慮停用Ajovy並採取適當的治療措施。.。Hypertension:高血壓：Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Ajovy, in the postmarketing setting.在上市後使用CGRP拮抗劑（包括Ajovy）的報告中，出現了高血壓的發展和原有高血壓惡化的現象。Monitor patients treated with Ajovy for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of Ajovy is warranted監測接受Ajovy治療的患者是否出現新發高血壓或原有高血壓惡化，並考慮是否需要停用Ajovy。.。Raynaud’s Phenomenon雷諾現象: 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拮抗劑（包括Ajovy）後，上市後的環境中已報告出現雷諾現象的發展以及先前存在的雷諾現象的復發或惡化。許多報告的病例出現了嚴重後果，包括住院和殘疾，通常與劇烈疼痛相關。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.如果出現雷諾現象的體徵或症狀，應停止使用Ajovy。有雷諾現象病史的患者應被監測，並被告知症狀可能惡化或復發的情況。Adverse Reactions:不良反應：The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.臨牀試驗中最常見的不良反應（≥5%且高於安慰劑）是注射部位反應。About Teva關於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製藥工業有限公司（紐約證券交易所和特拉維夫證券交易所代碼：TEVA）是一家領先的創新型生物製藥公司，依託世界級的仿製藥業務。在120多年的時間裏，Teva的承諾從未動搖。從在神經科學和免疫學領域的創新，到在全球範圍內提供複雜的仿製藥、生物類似藥和藥店品牌，Teva始終致力於滿足患者的需求，無論是現在還是未來。At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com..在特瓦，我們全力以赴追求更好的健康。欲瞭解更多信息，請訪問 www.tevapharm.com。Cautionary Note Regarding Forward-Looking Statements關於前瞻性陳述的注意事項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.本新聞稿包含1995年《私人證券訴訟改革法案》所指的前瞻性陳述，這些陳述基於管理層當前的信念和期望，並受到大量已知和未知風險及不確定因素的影響，這些風險和不確定因素可能導致我們未來的業績、表現或成就與此類前瞻性陳述中明示或暗示的內容存在重大差異。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.您可以根據諸如“應該”、“預期”、“預計”、“估計”、“目標”、“可能”、“預測”、“指引”、“打算”、“計劃”、“相信”等詞語及其在任何關於未來運營或財務表現的討論中具有相似含義和表達的術語來識別這些前瞻性陳述。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.可能導致或促成此類差異的重要因素包括與以下方面相關的風險：我們成功開發和商業化Ajovy（fremanezumab）用於預防兒童和青少年偶發性偏頭痛的能力；我們在市場中成功競爭的能力，包括我們開發和商業化其他醫藥產品的能力；我們成功執行“轉型增長”戰略的能力，包括擴展我們的創新藥和生物類似藥的產品線，並通過自主發展或業務拓展實現創新藥物和生物類似藥組合的盈利商業化；以及本新聞稿、截至2025年第二季度的10-Q表季度報告和截至2024年12月31日年度的10-K表年度報告中討論的其他因素，特別是標題為“風險因素”的部分。前瞻性聲明僅在其發佈之日有效，我們不承擔更新或修訂任何前瞻性聲明的義務。Source: Teva Pharmaceuticals來源：梯瓦製藥公司Ajovy (fremanezumab-vfrm) FDA Approval HistoryAjovy（fremanezumab-vfrm）FDA批准歷史Whatever your topic of interest,無論你感興趣的話題是什麼，subscribe to our newsletters訂閲我們的新聞通訊to get the best of Drugs.com in your inbox.獲取 Drugs.com 的最新資訊到您的郵箱。","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"}}}