Aflibercept

Therapeutic Aflibercept fusion antibody from the original Eylea® commercial drug

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PIGF
,
VEGF-A
Fusion protein
Eylea®
40 mg/mL
20 µL
0,8 mg
2-8°C / -80°C
11/2021
1.751,00 
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Eylea® / Aflibercept Reference Product

Drug nameEylea®
INNAflibercept
API typeFusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology
Pharmacotherapeutic group
Ophthalmologicals / Antineovascularisation agents
ATC code
S01LA05
Target of antibody
Vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF)
General functionAflibercept is an engineered protein that has been designed to attach to and block the effects of a substance called vascular endothelial growth factor A (VEGF-A). It can also attach to other proteins such as placental growth factor (PlGF). VEGF-A and PlGF are involved in stimulating the abnormal growth of blood vessels in patients with AMD, certain types of macular oedema and myopic choroidal neovascularisation. By blocking these factors, aflibercept reduces the growth of the blood vessels and controls the leakage and swelling.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and PlGF with higher affinity than their natural receptors, and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)Wet AMD is characterised by pathological choroidal neovascularisation (CNV). Leakage of blood and fluid from CNV may cause retinal thickening or oedema and/or sub-/intra-retinal haemorrhage, resulting in loss of visual acuity. In patients treated with Eylea, central retinal thickness [CRT] decreased soon after treatment initiation, and the mean CNV lesion size was reduced.
Original license holder
Bayer AG
Müllerstraße 178
13353 Berlin
Germany
Marketing authorisation numbers
EU/1/12/797/002
Marketing authorisation holder
Bayer AG
51368 Leverkusen
Germany
Name of the manufacturer of the biological active substance
Regeneron Pharmaceuticals, Inc. 81 Columbia Turnpike Rensselaer, New York 12144 USA
Name and address of the manufacturer(s) responsible for batch releaseBayer AG
Müllerstraße 178
13353 Berlin
Germany
Max shelf life
24 months
Storage conditions
2°C – 8°C
List of excipients
Polysorbate 20
Sodium dihydrogen phosphate, monohydrate
Disodium hydrogen phosphate, heptahydrate
Sodium chloride
Sucrose
Evidentic Support
+49 (0) 30 959 99 8831

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