Evolocumab drug aliquots can be used for in vitro or in vivo experiments. Several other reference drugs are also available.
The drug aliquots are generated by aliquoting (dividing and repackaging) the EU-licensed reference drug.
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Up to 10 batches of original drugs for examining batch-to-batch variations
Up to 80% less compared to the original pharmaceutical price
Shipment within days worldwide according to GDP-standards
Up to 80% less compared to the original pharmaceutical price
| Drug name | Repatha® |
| INN | Evolocumab |
| API type | Monoclonal antibody |
| Pharmacotherapeutic group | Lipid modifying agents, other lipid modifying agents |
| ATC code | C10AX13 |
| Target of antibody | PCSK9 |
| General function | |
| Short description | Evolocumab is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and in paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia, as an adjunct to diet. It is also indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies as well as in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors. |
| Pharmacodynamic properties (Mechanism of action; Source EMA document) | Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C). |
| Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document) | In clinical trials, evolocumab reduced unbound PCSK9, LDL-C, TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 in patients with primary hypercholesterolaemia and mixed dyslipidaemia. A single subcutaneous administration of 140 mg or 420 mg evolocumab resulted in maximum suppression of circulating unbound PCSK9 by 4 hours followed by a reduction in LDL-C reaching a mean nadir in response by 14 and 21 days, respectively. Changes in unbound PCSK9 and serum lipoproteins were reversible upon discontinuation of evolocumab. No increase in unbound PCSK9 or LDL-C above baseline was observed during the washout of evolocumab suggesting that compensatory mechanisms to increase production of PCSK9 and LDL-C do not occur during treatment. Subcutaneous regimens of 140 mg every 2 weeks and 420 mg once monthly were equivalent in average LDL-C lowering (mean of weeks 10 and 12) resulting in -72% to -57% from baseline compared with placebo. Treatment with evolocumab resulted in a similar reduction of LDL-C when used alone or in combination with other lipid-lowering therapies. |
| Original license holder | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Marketing authorisation numbers | EU/1/15/1016/003 |
| Marketing authorisation holder | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands |
| Name of the manufacturer of the biological active substance | Amgen Manufacturing Limited Road 31 km 24.6 Juncos Puerto Rico, 00777 United States Immunex Rhode Island Corporation 40 Technology Way West Greenwich Rhode Island, 02817 United States |
| Name and address of the manufacturer(s) responsible for batch release | Amgen Europe B.V. Minervum 7061 4817 ZK Breda The Netherlands Amgen Technology (Ireland) Unlimited Company Pottery Road Dun Laoghaire Co Dublin Ireland Amgen NV Telecomlaan 5-7 1831 Diegem Belgium |
| Max shelf life | 36 months |
| Storage conditions | 2°C – 8°C |
| List of excipients | Proline Glacial acetic acid Polysorbate 80 Sodium hydroxide (for pH adjustment) Water for injections |
Evidentic offers multiple batches of original drug aliquots in low binding Eppendorf tubes for research use only. We provide licence-free drug aliquots with long, short or even “negative shelf life” by storing the products at recommended temperatures (either 2-8°C or -80°C) and ensuring fully functional molecules for research purposes.
Evidentic GmbH
Am Mühlenberg 10
14476 Potsdam | Germany
