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Fremanezumab for the prevention of chronic and episodic migraine

机译：Fremanezumab用于预防慢性和巨型偏头痛

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摘要

On September 15, 2018, the U.S. Food and Drug Administration (FDA) approved subcutaneous fremanezumab, a calcitonin gene-related peptide (CGRP) monoclonal antibody, for the treatment of episodic and chronic migraine in adults, with two recommended dosages: 225 mg monthly or 675 mg every 3 months. On March 28, 2019, the European Commission granted fremanezumab Marketing Authorization in the E.U. for the same indication. In this monograph we review data on the pharmacokinetics, metabolism and safety of fremanezumab as reported in the scientific literature from phase I to phase III studies. Fremanezumab demonstrated a very low incidence of adverse events. Primary and secondary endpoints in randomized, controlled trials on the efficacy of fremanezumab were achieved. Fremanezumab was demonstrated to be able to reduce the number of migraine days, headache hours and number of days with use of acute treatment agents. No data on drug-drug interactions with fremanezumab are available. However, it is worth mentioning that fremanezumab showed a very low incidence of development of adverse drug antibodies compared with other CGRP antibodies.
机译：2018年9月15日，美国食品和药物管理局（FDA）批准了皮下Fremanezumab，一种降钙素基因相关的肽（CGRP）单克隆抗体，用于治疗成人中的嗜酸性和慢性偏头痛，每月有两个推荐剂量：225毫克或每3个月每375毫克。 2019年3月28日，欧洲委员会在E.U中授予Fremanezumab营销授权。对于相同的指示。在本专着中，我们审查了弗里蒙扎姆的药代动力学，代谢和安全性，从I阶段III研究中报告。 Fremanezumab表现出很低的不良事件发生率。达到了对弗雷曼扎姆布的疗效的随机，对照试验中的初级和次要终点。弗雷曼扎姆布被证明能够减少偏头发日，头痛时间和使用急性治疗剂的天数。没有关于药物 - 药物与Fremanezumab的数据。然而，值得一提的是，与其他CGRP抗体相比，Fremanezumab表现出极低的不良药物抗体发育发生率。

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