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Published in: Drugs 18/2019

01-12-2019 | Macular Degeneration | AdisInsight Report

Brolucizumab: First Approval

Author: Anthony Markham

Published in: Drugs | Issue 18/2019

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Abstract

Brolucizumab (Beovu®) is a low molecular weight, single-chain antibody fragment vascular endothelial growth factor (VEGF) inhibitor being developed by Novartis for the treatment of exudative (wet) age-related macular degeneration (AMD), diabetic macular oedema and macular oedema secondary to retinal vein occlusion. Based primarily on the results of the phase III HAWK and HARRIER trials brolucizumab was recently approved in the US for the treatment of wet AMD. This article summarizes the milestones in the development of brolucizumab leading to this first approval.
Literature
2.
go back to reference Novartis. Novartis receives FDA approval for BEOVU®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept [media release]. 8 Oct 2019. https://www.prnewswire.com. Novartis. Novartis receives FDA approval for BEOVU®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept [media release]. 8 Oct 2019. https://​www.​prnewswire.​com.
4.
go back to reference Alcon. Alcon and Novartis complete merger and form new Alcon Division to accelerate global leadership in eye care [media release]. 8 Apr 2011. http://www.alcon.com. Alcon. Alcon and Novartis complete merger and form new Alcon Division to accelerate global leadership in eye care [media release]. 8 Apr 2011. http://​www.​alcon.​com.
5.
6.
go back to reference Gaudreault J, Gunde T, Floyd HS, et al. Preclinical pharmacology and safety of ESBA1008, a single-chain antibody fragment, investigated as potential treatment for age related macular degeneration. Invest Ophthalmol Vis Sci. 2012;53(14):3025. Gaudreault J, Gunde T, Floyd HS, et al. Preclinical pharmacology and safety of ESBA1008, a single-chain antibody fragment, investigated as potential treatment for age related macular degeneration. Invest Ophthalmol Vis Sci. 2012;53(14):3025.
7.
go back to reference Tietz J, Spohn G, Schmid G, et al. Affinity and potency of RTH258 (ESBA1008), a novel inhibitor of vascular endothelial growth factor a for the treatment of retinal disorders [abstract]. Invest Ophthalmol Vis Sci. 2015;56(7):1501. Tietz J, Spohn G, Schmid G, et al. Affinity and potency of RTH258 (ESBA1008), a novel inhibitor of vascular endothelial growth factor a for the treatment of retinal disorders [abstract]. Invest Ophthalmol Vis Sci. 2015;56(7):1501.
8.
go back to reference Holz FG, Dugel PU, Weissgerber G, et al. Single-chain antibody fragment VEGF inhibitor RTH258 for neovascular age-related macular degeneration: a randomized controlled study. Ophthalmology. 2016;123(5):1080–9.CrossRef Holz FG, Dugel PU, Weissgerber G, et al. Single-chain antibody fragment VEGF inhibitor RTH258 for neovascular age-related macular degeneration: a randomized controlled study. Ophthalmology. 2016;123(5):1080–9.CrossRef
9.
go back to reference Nimz EL, Van TLCW, Yanez JA, et al. Intraocular and systemic pharmacokinetics of brolucizumab (RTH258) in nonhuman primates [abstract]. Invest Ophthalmol Vis Sci. 2016;57(12):4996. Nimz EL, Van TLCW, Yanez JA, et al. Intraocular and systemic pharmacokinetics of brolucizumab (RTH258) in nonhuman primates [abstract]. Invest Ophthalmol Vis Sci. 2016;57(12):4996.
11.
go back to reference Singh RP, Wykoff CC, Tadayoni R, et al. Visual and expanded anatomical outcomes for brolucizumab versus aflibercept in patients with neovascular AMD: 96-week data from HAWK and HARRIER [abstract]. Investig Ophthalm Vis Sci. 2019;60(9):5194. Singh RP, Wykoff CC, Tadayoni R, et al. Visual and expanded anatomical outcomes for brolucizumab versus aflibercept in patients with neovascular AMD: 96-week data from HAWK and HARRIER [abstract]. Investig Ophthalm Vis Sci. 2019;60(9):5194.
12.
go back to reference Dugel PU, Lang GE, Razavi S, et al. Predictability of the 12-week dosing status at week 48 for patients receiving brolucizumab in HAWK and HARRIER [abstract]. Investig Ophthalm Vis Sci Conf. 2018;59(9):1455. Dugel PU, Lang GE, Razavi S, et al. Predictability of the 12-week dosing status at week 48 for patients receiving brolucizumab in HAWK and HARRIER [abstract]. Investig Ophthalm Vis Sci Conf. 2018;59(9):1455.
13.
go back to reference Dugel PU, Jaffe GJ, Sallstig P, et al. Brolucizumab versus aflibercept in participants with neovascular age-related macular degeneration: a randomized trial. Ophthalmology. 2017;124(9):1296–304.CrossRef Dugel PU, Jaffe GJ, Sallstig P, et al. Brolucizumab versus aflibercept in participants with neovascular age-related macular degeneration: a randomized trial. Ophthalmology. 2017;124(9):1296–304.CrossRef
Metadata
Title
Brolucizumab: First Approval
Author
Anthony Markham
Publication date
01-12-2019
Publisher
Springer International Publishing
Published in
Drugs / Issue 18/2019
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-019-01231-9

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