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Amgen's cholesterol drug shows positive effect in cardiovascular outcomes study


Doctors don't know whether Praluent would also prevent heart attacks, Rind said. In contrast, in the real-world setting based on an analysis of patients in the UK CPRD database, an event rate of 12.3 (for all events) was observed.

Given that many patients at risk of a heart attack or stroke have little else to try, he says, this is "absolutely an advance in cardiovascular medicine".

It means that if all 325,000 eligible Britons were to be treated, 2,200 potentially fatal heart emergencies would be avoided every year. Almost all were taking modest or large doses of statins. The drug's mechanism of action was discovered by studying people with mutations to the gene for PCSK9 that allowed them to maintain exceptionally low cholesterol levels.

Evolocumab is an antibody, just like the weapons used by the immune system to fight infection, but has been created to target a protein in the liver with the name PCSK9.

Stubbornly high cholesterol is a key risk factor.

Amgen and Sanofi/Regeneron have been hoping that new data showing that reductions in LDL cholesterol (LDL-c) are mirrored by significant reductions in the cardiovascular complications of high cholesterol will drive uptake, and Amgen reported the results of its outcomes trial-Fourier-at the American College of Cardiology (ACC) meeting over the weekend.

"Our results suggest this new, extremely potent class of drug can cut cholesterol dramatically, which could provide great benefit for a lot of people at risk of heart disease and stroke", said Professor Peter Sever from Imperial College London, and the United Kingdom branch lead of the study, according to The New Daily. The detailed results are being published simultaneously in the New England Journal of Medicine. Unlike an antibiotic, which patients take for a few days or weeks, those prescribed Repatha would take it for the rest of their lives.

Those who took both were less likely to suffer a heart attack or stroke than if they took statins alone.


This reduction in risk improved over time, increasing from 16 per cent in the first year to 25 per cent after the first year, the researchers said.

On Friday, for the first time, we saw the full data from the FOURIER clinical trial of Amgen's cholesterol-lowering antibody, evolocumab (Repatha™).

They were followed up regularly for a subsequent eight months and tested for blood cholesterol and side effects. We continue to see Amgen's broad portfolio and newer drugs-including approved drugs Repatha and Kyprolis, novel pipeline therapies, and an industry-leading biosimilar pipeline-as providing a wide economic moat and a buffer to biosimilar threats to the older Enbrel and Neulasta franchises.

Inclisiran belongs to a new class of medicines that block a protein known as PCSK9, which prevents the removal of LDL from the blood.

"When we see a trial like this, I think that the use is going to up exponentially", she added, describing the study - the largest and most extensive of its kind to date when it comes to Repatha - as "pretty exciting". Depending on who you listen to, it was either "the most important study in at least 20 years" or a damp squib.

However, each doctor JP Morgan spoke to remained well grounded to the realities of its healthcare system and expressed their belief that these data would result in a meaningful easing of payer restrictions, but more work needs to be done to identify higher risk patient segments.

"It sounds like the patient gets harmed and the payer has its financial risk reduced", said New York-Presbyterian Hospital/Weill Cornell Medical Center cardiologist Cam Patterson.

Amgen believes it has the cardiovascular outcomes data it needs to inject some renewed momentum into its laggard cholesterol-lowering antibody Repatha, but reaction to the results has been muted.

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