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Europe expands approved indication of Amgen's Repatha in cardiovascular disease

Published on 17/05/18 at 11:14am

Amgen has revealed that its PCSK9 inhibitor Repatha (evolocumab) has received approval from the European Commission in a new indication: to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels in adult patients with established atherosclerotic cardiovascular disease, such as myocardial infarction, stroke or peripheral arterial disease.

The EC’s came to the decision based on positive data from a Repatha cardiovascular outcomes study which demonstrated that, compared to placebo and statin therapy, Amgen’s drug reduced the risk of heart attack and stroke by 27% and 21% respectively, as well as lowered the risk of coronary revascularisation procedures by 22% when used in combination with statins over a treatment period of 26 months.

Repatha’s proven ability to lower LDL-C, or “bad cholesterol”, for high-risk patients and therefore lower their risk of cardiovascular disease is seen as crucial when high LDL-C is known to be one of the most impactful factors on CVD risk.  

"With its proven ability to prevent heart attacks and strokes, Repatha offers hope for one of the greatest health challenges we face today. However, the majority of patients in Europe who could benefit from treatment with a PCSK9 inhibitor remain unserved and at risk of a cardiovascular event," commented Anthony C Hooper, Executive Vice President of Global Commercial Operations at Amgen. "To help ensure eligible patients around the world can access and benefit from Repatha, Amgen is willing to work in partnership with payers to help manage affordability concerns from increased patient access. Furthermore, we are committed to excellence in LDL-C management and collaborating with healthcare providers to deliver comprehensive solutions for patients."

Amgen’s executive vice president of Research and Development, Dr Sean E Harper, also remarked: "We know that patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year. With far too many patients at risk of recurrent cardiovascular events, we are pleased that the European Commission has approved Repatha to prevent heart attacks and strokes in adults with established atherosclerotic cardiovascular disease. The science clearly indicates that 'lower LDL-C is better' and this approval underscores the role for Repatha among high-risk patients for whom statins alone are not enough."

Matt Fellows

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