Published: Mon, March 20, 2017
Research | By Jo Caldwell

Amgen cholesterol drug 'cuts heart attack'

Amgen cholesterol drug 'cuts heart attack'

Sales of Repatha totalled $141 million past year.

By 2021, Repatha sales are expected to reach $3.9 billion, according to the consensus estimate compiled by FactSet.

Aiming to address questions about its cognitive effects, researchers at Brigham and Women's Hospital in collaboration with Brown University and the University of Geneva ran cognitive tests on almost 2,000 people enrolled in a two-year study of the drug. Although investors will likely have mixed feelings about this, MDCO has run many successful large studies in the past so they are not deterred by doing so again in a category which they believe they can reinvigorate. "It is a very good story in that regard", said Amgen's Harper.

Meanwhile, another study is underway to test a similar drug called Praluent, and see whether it too lowers heart risks. Repatha's 15% risk reduction on the primary endpoint-a composite that included cardiac death, hospitalization and revascularization procedures-means that preventing a CV "event" will be costly, Bernstein analyst Ronny Gal said in a Friday note. It showed widely varying effects on LDL cholesterol levels and had no benefit for people with LDL levels below 100, although patients with higher LDL levels did see significant benefits. The agency authorized its use when accompanied by a healthy diet and a statins treatment in patients with Homozygous Familial Hypercholesterolemia (HoFH), Atherosclerotic Cardiovascular Disease, and people in need of reducing their LDL cholesterol levels.

Half of the patients were asked to take optimal quantity of statins along with Repatha.

A second study of another PCSK9 inhibitor, bococizumab, was much less successful and was terminated, they reported Friday. The FDA approved Repatha and Regeneron Pharma's (REGN) Praluent on that basis.

However, new drug evolocumab changes the way the liver works to also cut bad cholesterol. 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".

The positive update will be a big boost to the high-cost drug, whose prescriptions have been facing massive rejections by pharmacy benefit managers and health insurers due to its high list price of $14,000 for one year of treatment. Investment bank RBC had viewed a 15%-24% reduction in the risk of cardiovascular outcomes as strong. The findings were presented at the American College of Cardiology annual conference. In an editorial in The New England Journal of Medicine, Dr. Robin Dullaart, a researcher at the University of Groningen in the Netherlands, called it a landmark study.

Bad cholesterol is the villain in heart world.

The group which had received evolocumab experienced fewer primary endpoint events, compared to the placebo arm of the study, with 1,344 (9.8 per cent) compared to 1,563 (11.3 per cent) respectively. This includes offering a refund on the drug for any patient who has a heart attack or stroke while using it.

At an absolute risk reduction of 1.5 percent to 2 percent over 2.2 years, the number needed to treat to prevent an even is in the range of 65 to 75 patients.

"That reduction in risk is meaningful - but no new records on risk reduction were set".

After about two years, Repatha, used along with statins, reduced LDL from a median of 92 to 30. The new study gives that evidence, but the benefit is not as great as some doctors had hoped.

The drug reduced the rate of heart attacks 27 percent, stroke 21 percent, and stents and heart bypass procedures 22 percent. "Indeed, it does for treatment of lipids in coronary artery disease today what TNT did over a decade ago - it shows us that lower is better and safe in the mid-term".

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