Evolocumab, added to statins may help lower cholesterol

The injectable drug Repatha can lower cholesterol to unheard-of levels. The next question is whether the disease-prevention benefit it worth its high price

The injectable drug Repatha can lower cholesterol to unheard-of levels. The next question is whether the disease-prevention benefit it worth its high price

"The prices that are actually being paid by payers in the USA marketplace today, after the rather large rebating that goes on, are right in the middle of the value range for a product like this".

Still, Elliott Levy, Amgen's senior vice president of global development, said the study results were "about as good a result as you can get".

Amgen, though, claims that Repatha is worth the price and its value has been proven conclusively with the study.

"These results, I think, will mean the guidelines are adjusted slightly, but unless the price comes down it won't mean we give it to anyone by any means", said Professor Naveed Sattar, a metabolic medicine expert of the University of Glasgow, according to The Daily Mail. The shares were down on the data, as the risk reduction on the primary endpoint (15%) was at the low end of expectations, despite still being significant. The top line here is that for this population, it is going to be hard to justify the cost of these [PCSK9] medicines for the magnitude of the risk reduction, Weiss added. Insurance companies have been trying to escape costly Repatha and have asked the company to provide better proof of reduction in heart disease risk.

The patients in the trial were already taking statins, which are used to reduce low-density lipoprotein (LDL) cholesterol.

The ORION-1 trial presented at ACC looked at the effects on LDL-c of one or two injections of inclisiran at three doses (200 mg, 300 mg and 500 mg) compared to placebo over more than six months, and updated previous results reported past year. The FDA approved Repatha and Regeneron Pharma's (REGN) Praluent on that basis.

Amgen's cholesterol drug Repatha (evolocumab) has showed positive effect in a 27,564-patient cardiovascular outcomes study. The researchers randomized patients to receive either injections of Repatha or placebo, and followed them for 2 years to track several cardiovascular events: heart attack, stroke, death, hospitalization for blocked blood flow to the heart, and stent or bypass surgery.

Neurocognitive adverse events, in the full cohort, were reported for 19 (1.9%) in the evolocumab group, compared to 16 (1.6%) in the placebo group. The difference equates to a 1.5 percentage point absolute reduction in cardiovascular outcome risk and a 15% relative reduction favoring Repatha.

As a result, manufacturers decided to make a clinical trial, and they presented the results at the American College of Cardiology meeting held last Friday.

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The PCSK9 protein helps to control the amount of bad cholesterol in the blood by regulating the number of LDL receptor proteins on cell surfaces, which take LDL out of circulation.

Nearly 14,000 patients were recruited to the treatment arm of the study, receiving the drug over a 48-week period.

According to a statement published in The New England Journal of Medicine, the study included 27,564 patients between 40 and 85 years old with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter or higher.

The investigators who conducted the FOURIER study noted Repatha's benefit grows over time.

"It's remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years".

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.

Amgen believes the numbers are strong enough to change clinical practice, though.

"However, the trial was stopped early after only 2.2 years of average follow-up", Sir Nilesh said.

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