Amgen 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. 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. 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," said Sean E. Harper, M.D., 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 per cent, the risk of stroke by 21 per cent and the risk of coronary revascularisation procedures by 22 per cent in patients treated with Repatha and statin therapy compared to patients treated with placebo and statin therapy over a mean duration of 26 months.

Our commitment to improve access for high-risk patients in Europe mirrors the efforts in the US where over the last several months, Amgen has offered payers meaningful reductions in price for those who significantly improve access.

The 27,564-patient Repatha cardiovascular outcomes study (FOURIER) demonstrated that adding Repatha to optimised statin therapy resulted in a statistically significant 20 percent (p<0.001) reduction in major adverse cardiovascular events (MACE) represented in the key secondary composite endpoint of time to first heart attack, stroke or cardiovascular death. The study found a statistically significant 15 percent reduction (p<0.001) in the risk of the primary composite endpoint, which included hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death.

The magnitude of risk reduction in both the primary and key secondary composite endpoints grew over time, with the robust benefit starting as early as six months and accruing through the median 2.2 years of the study.

Patients on Repatha experienced a reduction in the risk of heart attack (27 per cent, nominal p<0.001), stroke (21 per cent, nominal p=0.01) and coronary revascularisation (22 per cent, nominal p<0.001). There was no observed effect on hospitalisations for unstable angina. Consistent with recent trials of more intensive LDL-C lowering, there was no significant effect on cardiovascular mortality.

The safety profile of Repatha in the outcomes trial was generally consistent with the safety profile for the 12- and 52-week controlled trials involving patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).

FOURIER (Further Cardiovascular OUTcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), a multinational phase 3 randomised, double-blind, placebo-controlled trial, is designed to evaluate whether treatment with Repatha in combination with high- or moderate-intensity statin therapy compared to placebo plus statin therapy reduces cardiovascular events. The hard MACE composite endpoint was the time to cardiovascular death, myocardial infarction or stroke (key secondary endpoint). The extended MACE composite endpoint was the time to cardiovascular death, myocardial infarction, stroke, or hospitalisation for unstable angina or coronary revascularisation (primary endpoint).

Eligible patients with high cholesterol (LDL-C =70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] =100 mg/dL) and established cardiovascular disease at more than 1,300 study locations around the world were randomised to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus high- or moderate-intensity effective statin dose; or placebo subcutaneous every two weeks or monthly plus high- to moderate-intensity statin dose. Statin therapy was defined in the protocol as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.