Faricimab: First Approval
Faricimab: First Approval
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Faricimab：首次批准
DOI：
10.1007/s40265-022-01713-3
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发表时间：
2022
期刊：
影响因子：
11.5
通讯作者：
M. Shirley
中科院分区：
文献类型：
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作者：
M. Shirley
Faricimab(Faricimab-svoa；Vabysmo™)是一种双功能抗体，可与血管内皮生长因子-A和血管生成素-2结合并抑制。通过玻璃体内注射，罗氏/基因泰克公司正在开发Faricimab，用于治疗视网膜血管疾病。2022年1月，Faricimab在美国首次获得批准，用于治疗新生血管(湿)老年性黄斑变性(NAMD)或糖尿病黄斑水肿(DME)患者。Faricimab最近也在日本获得批准，目前正在欧盟接受监管审查，用于NAMD和DME。FARICIMAB的第三阶段临床开发用于治疗NAMD、DME和视网膜静脉阻塞引起的黄斑水肿，目前正在全球多个其他国家继续进行。这篇文章总结了Faricimab开发过程中的里程碑，导致NAMD和DME在美国首次获得批准。
Faricimab (faricimab-svoa; Vabysmo™) is a bispecific antibody that binds to and inhibits both vascular endothelial growth factor (VEGF)-A and angiopoietin-2 (Ang-2). Administered by intravitreal injection, faricimab is being developed by Roche/Genentech for use in the treatment of retinal vascular diseases. In January 2022 faricimab received its first approvals, in the USA, for use in the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) or diabetic macular edema (DME). Faricimab has also recently been approved in Japan, and is currently under regulatory review in the EU, for use in nAMD and DME. Phase III clinical development of faricimab for use in the treatment of nAMD, DME, and macular edema due to retinal vein occlusion is continuing in multiple other countries worldwide. This article summarizes the milestones in the development of faricimab leading to these first approvals for nAMD and DME in the USA.