Erenumab (Genetical Recombination)

Recommends therapies targeting calcitonin gene-related peptide (CGRP) as a first-line option for migraine prevention MOUNT ROYAL, N.J., March 11, 2024 /PRNewswire/ -- The American Headache Society (AHS) published a consensus position statement today in Headache: The Journal of Head and Face Pain about the first-line role CGRP-targeting therapies should play in the prevention of migraine. Specifically, the AHS calls for CGRP-targeting therapies to be considered as a first-line approach for migraine prevention, along with previous first-line treatments, without a requirement for prior failure of other classes of migraine preventive treatment. The goal of preventive treatment is to reduce the frequency, intensity, duration, and disability associated with migraine attacks. AHS, the leading medical and scientific organization for healthcare professionals in migraine and other headache disorders, estimates that preventive therapy is indicated for approximately 40% of people with migraine, and many are unable to use existing first-line preventive migraine medicines due to limited effectiveness and tolerability. After a comprehensive review of clinical trial and real-world experience, the AHS found the evidence supporting the efficacy, tolerability, and safety of CGRP-targeting therapies—such as monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) and small-molecule CGRP receptor antagonists (rimegepant and atogepant)—for migraine prevention to be substantial in its volume, scope, and quality. "Moving CGRP-targeting therapies to the first line of treatment could have a transformational impact on the prevention of migraine attacks and their associated burdens," said Andrew Charles, MD, FAHS, position statement co-author and president of the American Headache Society. "Elevating CGRP-targeting therapies to the first line should reduce barriers for patients to receive these effective treatments and bring hope to countless people who experience this invisible, yet debilitating disease." The new position statement from the AHS, "Calcitonin gene-related peptide (CGRP)-targeting therapies are a first-line option for the prevention of migraine," provides guidance on how to integrate these treatments into clinical practice. ABOUT MIGRAINE Migraine is the third most common disease in the world. In the United States, an estimated 40 million Americans live with migraine. While migraine symptoms vary from person to person, common symptoms include severe headache; nausea and/or vomiting; increased sensitivity to light, sound, or smells; depressed mood or changes in mood; and yawning, fatigue, and difficulty sleeping. ABOUT THE AMERICAN HEADACHE SOCIETY The American Headache Society strives to improve the lives of people impacted by migraine and other headache disorders. The AHS is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society's objective is to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals, and the public while encouraging scientific research are the primary functions of our Society. Learn more at AmericanHeadacheSociety.org. This consensus statement published by the American Headache Society (AHS) is an assessment of current scientific and clinical information that is provided as an educational service. The information should not be considered inclusive of all appropriate treatments. New evidence may develop between the time this statement is submitted and when it is published or read. This statement addresses only the question that is specifically identified. It does not mandate any particular course of medical care and is not intended to substitute for the independent professional judgment of the treating provider. CONTACT Tanya Kiniry [email protected] SOURCE American Headache Society

近日，据 CDE 临床试验登记与信息公示平台，艾伯维 Atogepant 国内启动一项新 III 期临床 ECLIPSE 研究，用于偏头痛急性发作治疗（登记号：CTR20240519）。来自：CDE 官网不过，在今年 2 月，艾伯维已经在 ClinicalTrials.gov 上登记了该临床研究（登记号：NCT06241313）。ECLIPSE 研究计划全球入组 1300 名受试者，国内 260 名，并预计于 4 月 30 日完成全球首例受试者的入组工作。艾伯维 Atogepant 是一款口服 CGRP 受体拮抗剂，2021 年获 FDA 批准用于预防成人发作性偏头痛。去年 4 月，FDA 批准扩大适应症至成人慢性偏头痛的预防性治疗，Atogepant 成为唯一一款被批准用于治疗发作性和慢性偏头痛的口服 CGRP 拮抗剂。同年 8 月，Atogepant 获 EMA 批准上市，用于预防每月至少有四天偏头痛的成人患者。在国内，此前已启动了一项试验地区包括中国内地的全球多中心 III 期临床试验，用于慢性偏头痛预防治疗（登记号：CTR20192279）。此后对于已完成该研究的中国参与者，单独开展了一项 III 期临床，旨在评估 Atogepant 60mg 每日一次，持续 12 周，用于预防偏头痛的安全性、耐受性以及疗效（登记号：CTR20211591）。而本次登记启动的 III 期临床则是针对于偏头痛急性发作治疗。据艾伯维财报，Atogepant 2023 年销售额已达 4.08 亿美元。艾伯维预计，Atogepant 有望达到 10 亿+美元的销售峰值。百亿偏头痛市场已吸引全球各大企业布局。据 Insight 数据库，当前全球范围内已有 8 款靶向 CGRP 的偏头痛治疗药物获批上市。前 3 款均为注射剂，在 2018 年度先后获批，2019 年以艾伯维 Ubrogepant 为首，口服药开始陆续获批，2023 年辉瑞/Biohaven 还推出新的剂型鼻喷雾剂，为偏头痛患者提供多样治疗选择。全球获批上市的 CGRP 靶向药来自：Insight 数据库网页版（下同）从市场规模上看，2023 年全年销售未全部公布，但从 2022 年来看，8 款 CGRP/CGRPR 抑制剂的全球销售收入达到 29.01 亿美元，整体呈现稳步增长的态势，艾伯维、礼来和安进市场份额最突出。此外，2022 年辉瑞斥资 116 亿美元收购 Biohaven，进军偏头痛市场，从 2023 年已公布销售额数据来看，辉瑞当前已占据一定市场份额。已上市 CGRP 靶向药过去 3 年全球销售额在国内，则刚从 2023 年开始密集获批上市。诺华的 CGRPR 单抗依瑞奈尤单抗/Erenumab，礼来 CGRP 单抗 Galcanezumab 以及辉瑞 CGRP 拮抗剂 Rimegepant 均在去年获批上市。而对于国产企业而言，当前仅有君实生物开发的 JS010 进入临床阶段，暂无其他企业布局。封面来源：站酷海洛 Plus免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：HebePR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn多样化功能、可溯源数据……Insight 数据库网页版等你体验点击阅读原文，立刻解锁！