Amgen cholesterol drug cuts heart attack, stroke risk but shares fall

21 March, 2017, 00:48 | Author: Lorraine Moran

Experts said the findings were the most important since the first statins trials two decades ago.

Analysts at Jefferies also think TMC's management can draw on those datasets for the design of ORION-4, which they suggest would likely involve 10-14,000 patients, have a two-year-plus follow-up and could-potentially-show a 30% reduction in cardiovascular events.

Amgen's FOURIER study enrolled 27,564 patients with a prior medical history of heart attack, stroke or other coronary artery disease.

"The magnitude of benefit on heart attacks and strokes are about what thoughtful people would have expected", he said, adding that he did not expect a death benefit after just 26 months. The implication, he said, is that larger benefit is "probably a true reflection of what patients will experience if they take the drug over time".

Millions of people consume drugs called statins to minimize the amount of bad cholesterol.

A powerful cholesterol drug cuts the risk of heart attacks by a quarter, a landmark trial has found.

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. The man-made antibody helps in cutting down the risk of cardiovascular and heart diseases related death in people by 20%.

In the study, published today in the New England Journal of Medicine, researchers looked at the protective effect of evolocumab on patients in 49 countries, with a history of atherosclerotic vascular disease, who were already taking statins to reduce their cholesterol.

Repatha shots are given once or twice in a month while patients take statins regularly. The benefit grew with longer use, and was 25 percent the second year, said Sabatine, who consults for Amgen and other drugmakers.

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Amgen said today it would offer a refund to payers that "lower access barriers" if patients on their plans taking evolocumab suffer a heart attack or stroke.

Yet Repatha's high cost could burden the US health system, said Dr. Steve Miller, senior vice president and chief medical officer at Express Scripts, a pharmacy benefit manager.

Fuster also noted that in absolute numbers, the drug saved about two percent of lives.

Evolocumab is a fully human monoclonal antibody that works by blocking proprotein convertase subtilisin-kexin 9 (PCSK) - a protein that reduces the liver's ability to remove LDL cholesterol from the blood.

The cost varies, but it is thought to cost the UK's NHS about £2,000 per year per patient where it is already being given to people who do not respond to statins. The fresh evidence could mean many more patients become eligible.

But it comes at a hefty price tag of more than $14,000 per year, raising concerns about how many patients could benefit. But in the Mizuho Securities conference call, participants agreed that a reasonable estimate of the direct hospital cost of treating a stroke is around $20,000 to $40,000, while the total lifetime costs are about $100,000 for an elderly patient, and up to $500,000 for a young patient.

"It sounds like the patient gets harmed and the payer has its financial risk reduced", said cardiologist Cam Patterson, chief operating officer at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who wasn't involved in the study.

Prof Sir Nilesh Samani, medical director at the British Heart Foundation, said: "Coronary heart disease is the single biggest killer in the United Kingdom and worldwide and "bad" LDL-cholesterol is a major cause".

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