Faricimab: First Approval

被引：107

作者：

Shirley, Matt ^{[1
]}

机构：

[1] Springer Nat, Private Bag 65901, Auckland 0754, New Zealand

来源：

DRUGS | 2022年 / 82卷 / 07期

关键词：

DIABETIC MACULAR EDEMA; OUTCOMES;

D O I：

10.1007/s40265-022-01713-3

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Faricimab (faricimab-svoa; Vabysmo (TM)) 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.

引用

页码：825 / 830

页数：6

共 19 条

[1] Building on the success of anti-vascular endothelial growth factor therapy: a vision for the next decade [J].

Adamis, Anthony P. ;

Brittain, Christopher J. ;

Dandekar, Atul ;

Hopkins, J. Jill .

EYE, 2020, 34 (11) :1966-1972

[2]

Baumal CR, 2020, AM J MANAG CARE, V26, pS103, DOI 10.37765/ajmc.2020.43435

[3]

Canonica J, 2021, INVEST OPHTH VIS SCI, V62

[4]

Chakravarthy U, 2017, OPHTHALMOL RETINA, V1, P474, DOI 10.1016/j.oret.2017.03.003

[5]

Chugai Pharmaceutical Co, 2022, CHUG OBT REG APPR VA

[6] Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: a real-world analysis of 28 658 patient eyes [J].

Ciulla, Thomas A. ;

Pollack, John S. ;

Williams, David F. .

BRITISH JOURNAL OF OPHTHALMOLOGY, 2021, 105 (02) :216-221

[7]

European Medicines Agency, 2021, COMM MED PROD HUM US

[8] Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study) [J].

Glassman, Adam R. ;

Wells, John A., III ;

Josic, Kristin ;

Maguire, Maureen G. ;

Antoszyk, Andrew N. ;

Baker, Carl ;

Beaulieu, Wesley T. ;

Elman, Michael J. ;

Jampol, Lee M. ;

Sun, Jennifer K. .

OPHTHALMOLOGY, 2020, 127 (09) :1201-1210

[9] Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials [J].

Heier, Jeffrey S. ;

Khanani, Arshad M. ;

Ruiz, Carlos Quezada ;

Basu, Karen ;

Ferrone, Philip J. ;

Brittain, Christopher ;

Figueroa, Marta S. ;

Lin, Hugh ;

Holz, Frank G. ;

Patel, Vaibhavi ;

Lai, Timothy Y. Y. ;

Silverman, David ;

Regillo, Carl ;

Swaminathan, Balakumar ;

Viola, Francesco ;

Cheung, Chui Ming Gemmy ;

Wong, Tien Y. .

LANCET, 2022, 399 (10326) :729-740

[10] THE ANGIOPOIETIN/TIE PATHWAY IN RETINAL VASCULAR DISEASES A Review [J].

Heier, Jeffrey S. ;

Singh, Rishi P. ;

Wykoff, Charles C. ;

Csaky, Karl G. ;

Lai, Timothy Y. Y. ;

Loewenstein, Anat ;

Schlottmann, Patricio G. ;

Paris, Liliana P. ;

Westenskow, Peter D. ;

Quezada-Ruiz, Carlos .

RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES, 2021, 41 (01) :1-19

← 1 2 →