The European Commission has expanded the scope of Amgen’s PCSK9 inhibitor Repatha to include the reduction of cardiovascular risk in adults with established atherosclerotic cardiovascular disease (CVD).
The drug can be used to reduce cardiovascular risk - by lowering low-density lipoprotein cholesterol (LDL-C) levels - as an adjunct to correction of other risk factors.
The decision rides on the back of data from the 27,564-patient cardiovascular outcomes study FOURIER, which showed that Repatha (evolocumab) cut the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularisation by 22 percent in patients with CVD.
The data demonstrated that adding Repatha to optimised statin therapy resulted in a statistically significant 15 percent reduction in the risk of the primary composite endpoint, which included hospitalisation for unstable angina, coronary revascularisation, heart attack, stroke or cardiovascular death.
Also, the study found a statistically significant 20 percent reduction in major adverse cardiovascular events (MACE) as per the key secondary composite endpoint of time to first heart attack, stroke or cardiovascular death.
“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 Harper, executive vice president of R&D at Amgen.
“With far too many patients at risk of recurrent cardiovascular events, we are pleased that the European Commission has authorised evolocumab to help prevent heart attacks and strokes in adults with established atherosclerotic cardiovascular disease.
“The science clearly indicates that lower LDL-C is better and this decision underscores the role for evolocumab among high-risk patients for whom statins alone are not enough.”
“With its ability to help prevent heart attacks and strokes, evolocumab 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,” added Anthony Hooper, executive vice president of Global Commercial Operations at Amgen.
The group said now the label has been updated it is “working to ensure that all eligible patients in the UK can access” the drug.