近日，Ajovy（fremanezumab-vfrm）获美国FDA批准为每月一次皮下注射，成为全球第二款靶向CGRP偏头痛的上市药物
  AJOVY是一种人源化单克隆抗体，与降钙素基因相关肽（CGRP）配体结合并阻断其与受体的结合，也是第一个也是唯一一个用于预防偏头痛的抗CGRP治疗，每季度（675毫克）和每月一次（225mg）剂量选择。
批准日期：2018年9月17日 公司：梯瓦（Teva）
AJOVY（fremanezumab-vfrm）注射液，用于皮下使用
美国最初批准：2018年
作用机制
Fremanezumab-vfrm是一种人源化单克隆抗体，可与降钙素基因相关肽（CGRP）配体结合并阻断其与受体的结合。
适应症和用法
AJOVY是一种降钙素基因相关的肽拮抗剂，适用于成人偏头痛的预防性治疗。
剂量和给药
•仅限皮下使用。
•AJOVY的两种皮下给药方案可用于推荐剂量：每月225mg，每3个月oro 675mg（每季度）
•675mg季度剂量以三次连续注射给药，每次225mg。
•皮下注射腹部，大腿或上臂。
•有关重要的管理说明，请参阅剂量和管理。
剂量形式和强度
注射：在单剂量预填充注射器中的225mg/1.5mL溶液。
禁忌症
AJOVY禁用于严重超敏tofremanezumab-vfrm或任何赋形剂的患者。
警告和注意事项
超敏反应：如果发生超敏反应，可考虑停用AJOVY并进行适当的治疗。
不良反应
最常见的不良反应（≥5％且大于安慰剂）是注射部位反应。
包装提供/存储和处理
提供
AJOVY（fremanezumab-vfrm）注射剂是一种无菌，无防腐剂，透明至乳白色，无色至微黄色的溶液，用于皮下给药。
预充式注射器帽不是用天然橡胶胶乳制成的。
AJOVY提供如下：
•NDC 51759-204-10：一个225mg/1.5mL单剂量预装注射器的纸箱
存储和处理
•在原始外箱中冷藏2°C至8°C（36°F至46°F），以防止光线照射。
•如有必要，AJOVY可在室温下保存在原始纸箱中，最高温度为25°C（77°F），最长可保持24小时。 从冰箱中取出后，AJOVY必须在24小时内使用或丢弃。
•不要冻结。

完产说明资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf

Ajovy Injection Approved for Migraine Prevention in Adults
Teva announced that the Food and Drug Administration (FDA) has approved Ajovy (fremanezumab-vfrm) subcutaneous injection for the preventive treatment of migraine in adults.
Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks it binding to the receptor. This is the first anti-CGRP drug for migraine prevention that is available as quarterly and monthly dosing regimens. Ajovy may be given as an in-office treatment by a healthcare professional or at home by the patient or a caregiver.
Two Phase 3, placebo-controlled trials (Study 1 and Study 2) evaluated Ajovy monotherapy and as combination therapy with oral preventive drugs in patients with disabling migraine.
Study 1 (N=875) randomized adults with a history of episodic migraine to receive subcutaneous Ajovy 675mg every 3 months, Ajovy 225mg monthly, or placebo monthly, for 3 months. The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Both monthly and quarterly dosing options of Ajovy showed statistically significant improvements for efficacy endpoints vs placebo over the 3-month period.
There was a reduction of  3.7days and 3.4 days of monthly migraine days (MMD) from baseline in the Ajovy 225mg monthly and Ajovy 675mg quarterly dosing groups, respectively, compared with 2.2 days in the placebo group.
Study 2 (N=1130) randomized adults with a history of chronic migraine to receive Ajovy 675mg followed by 225mg  monthly, 675mg every 3 months, or placebo monthly, for 3 months. The primary efficacy endpoint was the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 3-month treatment period. Both monthly and quarterly dosing options of Ajovy showed statistically significant improvements for efficacy endpoints vs placebo over the 3-month period. There was a reduction of -4.6 days and -4.3 days in the monthly average number of headache days of at least moderate severity in the Ajovy 225mg monthly and Ajovy 675mg quarterly dosing groups, respectively, compared with -2.5 days in the placebo group.
Injection site reactions were the most common adverse reactions associated with Ajovy.
Ajovy will be supplied as a 225mg/1.5mL strength, preservative-free, single-dose prefilled syringe. It is anticipated to launch in approximately 2 weeks.