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EU approves Repatha ( Evolocumab) for reduction of CV risk

The European Commission has expanded the scope of Amgen’s PCSK9 inhibitor Repatha ( evolocumab) 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 new indication is as follows:

“Established atherosclerotic cardiovascular disease:

Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

  • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Hypercholesterolaemia and mixed dyslipidaemia:

Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Homozygous familial hypercholesterolaemia:

Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.

Established atherosclerotic cardiovascular disease:

Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

  • in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
  • alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

“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.

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