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Amgen achieves positive results for cholesterol drug
Amgen has announced positive data from two phase III trials of its evolocumab treatment for reducing cholesterol.
Published in The Lancet, results from the TESLA and Rutherford-2 trials have shown the investigational low-density lipoprotein cholesterol-lowering medication produced a statistically-significant cut in patients with familial hypercholesterolemia (FH) when compared to a placebo.
FH is a hereditary condition caused by a gene mutation and can cause high levels of "bad" cholesterol, which may lead to premature cardiovascular disease.
Evolocumab inhibits proprotein convertase subtilisin/kexin type 9 – a protein proven to reduce the liver's ability to remove low-density lipoprotein cholesterol from the blood.
Sean Harper, executive vice president of research and development at Amgen, said: "Results from these two phase III studies support the effectiveness of evolocumab as a treatment option for patients with both forms of FH, who struggle to manage their cholesterol levels."
The latest data has been combined with that from other studies to form the basis of the company's submissions for approval of the drug from the US Food and Drug Administration and the European Medicines Agency.
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