Amgen’s cholesterol buster Repatha has become the first PCSK9 inhibitor to receive a regulatory approval anywhere in the world, following a green flag from the European Commission.

The closely watched drug has been deemed safe and effective by European regulators as a treatment for patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.

Highlighting significant unmet medical need, Amgen noted that more than 60% of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other medicines, a figure which is thought to be more than 80% in very high risk patients, putting them at a much higher risk from developing cardiovascular disease.

Repatha (evolocumab) is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or ‘bad’ cholesterol, from the blood.

Its approval in Europe is based on clinical trial data showing a reduction in LDL-C of some 55%-75% versus a placebo, and by around 35% to 45% compared with ezetimibe (Merck & Co’s Zetia), in patients with primary hyperlipidaemia and mixed dyslipidaemia. In patients with the high-risk homozygous familial hypercholesterolaemia, Repatha significantly cut LDL-C by about 15%-30% compared with placebo, Amgen said.

Repatha may have bagged the world’s first PCSK9 status, but Sanofi/Regeneron’s Praluent is snapping at its heels. Both drugs won backing from FDA advisors last month, while in Europe the position on Praluent could become clear any day now.