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Drugs. 2018 Nov;78(17):1829-1834. doi: 10.1007/s40265-018-1004-5.
Fremanezumab-vfrm (hereafter referred to as fremanezumab) [AJOVY™] is a fully humanized monoclonal antibody (IgG2Δa) developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Its use has been associated with significant reductions in migraine frequency, the requirement for acute headache medication use and headache-related disability compared with placebo in multinational, phase III studies, and in September 2018 fremanezumab was approved by the US FDA for the preventive treatment of migraine in adults. A regulatory assessment for fremanezumab as a preventive treatment of migraine in adults is underway in the EU. Fremanezumab is also undergoing phase III development for the preventive treatment of cluster headache (although a phase III chronic cluster headache study has been suspended due to the results of a prespecified futility analysis) and phase II development for the preventive treatment of post-traumatic headache disorder. This article summarizes the milestones in the development of fremanezumab leading to this first approval in the USA for the preventive treatment of migraine in adults.
依洛尤单抗（fremanezumab-vfrm，以下简称 fremanezumab）[AJOVY™]是由梯瓦制药公司开发的一种完全人源化单克隆抗体（IgG2Δa），用于选择性靶向降钙素基因相关肽（一种参与偏头痛病理生理学的血管扩张神经肽）。在多国三期研究中，与安慰剂相比，依洛尤单抗可显著降低偏头痛发作频率、急性头痛药物使用需求以及头痛相关残疾，并且在 2018 年 9 月，美国食品药品监督管理局（FDA）批准依洛尤单抗用于成人偏头痛的预防性治疗。依洛尤单抗在欧盟也正在进行成人偏头痛预防性治疗的监管评估。依洛尤单抗也正在进行预防性治疗丛集性头痛的三期开发（尽管由于预设无效性分析的结果，一项三期慢性丛集性头痛研究已暂停）和预防性治疗创伤后头痛障碍的二期开发。本文总结了依洛尤单抗开发过程中的重要里程碑，这使其在美国首次获批用于成人偏头痛的预防性治疗。
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