World first: Amgen’s PCSK9 inhibitor approved in EU

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.

by SELINA MCKEE

http://www.pharmatimes.com/Article/15-07-21/World_first_Amgen_s_PCSK9_inhibitor_approved_in_EU.aspx

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