New indication for evolocumab in established atherosclerotic cardiovascular disease

Amgen has announced announced that the European Commission (EC) has approved a new indication in the Repatha^® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels.

Amgen has announced announced that the European Commission (EC) has approved a new indication in the Repatha^® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels.

With the expanded label now in place, Amgen is working with payers in Europe to remove prescribing barriers and expand access in order to reach patients with established cardiovascular disease who are at risk of another event.

“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,” said 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.”

Of all the modifiable risk factors for heart attack and stroke, lowering high LDL-C is one of the most important and impactful.^1,2 Yet, even among patients currently taking a lipid-lowering therapy, many patients still have high LDL-C levels and remain at risk for cardiovascular events. Repatha is a groundbreaking medicine proven to significantly lower “bad cholesterol” or LDL-C for high-risk patients who suffer from a combination of high LDL-C and cardiovascular disease, and who continue to struggle with lowering their LDL-C levels despite statin therapy.

“We know that patients with a previous history of cardiovascular events are at an increased risk of subsequent events, especially in the first year,”^3-5 said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “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.”

The approval by the EC recognises the positive findings from the Repatha cardiovascular outcomes study (FOURIER), expanding the label to include data on the additional reduction and prevention of heart attacks, strokes and coronary revascularisations on top of maximally tolerated statin therapy. FOURIER showed reductions in the risk of heart attack by 27%, the risk of stroke by 21% and the risk of coronary revascularisation procedures by 22% in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.⁶

References

1. National Heart, Lung, and Blood Institute. How To Prevent and Control Coronary Heart Disease Risk Factors. Accessed April 10, 2018
2. Kuklina, EV. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol. United States, 1999–2002 and 2005–2008. MMWR. 2011;60(4):109–14
3. Mohan KM, et al. Stroke. 2011;42:1489-94
4. Bhatt DL, et al. JAMA.  2010;304:1350-7.
5. Jernberg, T., et al. Eur Heart J. 2015. 36(19), 1163-117
6. Sabatine MS, Giugliano RP, Keech AC, et al, for the FOURIER Steering Committee and Investigators. N Engl J Med. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. 2017;376:1713-22.