Drug name | Eylea®
|
INN | Aflibercept |
API type | Fusion 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 function | Aflibercept 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 release | Bayer 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 |
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