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Amgen's Repatha Reduces Cholesterol and Cuts Risk of Cardiovascular-related Deaths

Amgen's Repatha Reduces Cholesterol and Cuts Risk of Cardiovascular-related Deaths

Can shares of Amgen rebound from today's selloff? A group of patients was also treated with a placebo, and the results show that they were more likely to suffer a heart attack than patients taking Repatha.

These results were seen across all groups of patients, even in those who started with low levels of cholesterol. The current standard of care, a class of drugs called statins, are seemingly everywhere, but heart disease remains the leading cause of death in the US, according to the Centers for Disease Control and Prevention.

The refunds would go to insurance companies, not patients, Ofman said. An estimated 75% of prescriptions written for Repatha are rejected.

This was enough to convince the FDA to approve the drug, albeit with a limited label.

By 2021, Repatha sales are expected to reach $3.9 billion, according to the consensus estimate compiled by FactSet. "The next big challenge is financial: how to pay for it", says Dr. David Maron, director of preventive cardiology at Stanford, who also was not involved in the study.

"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".

Amgen may know that insurers are unlikely to accept their money-back guarantee, Patterson said.

The average age of the patients in the study was 63, and three-quarters of them were men.

Till now, with LDL, "no one was sure whether it was more like blood pressure and needed to be in range, or whether we want to eliminate it like tobacco", Levy said.

No one disputes that heart disease is a major medical problem. Patients were randomized to receive 140-mg evolocumab by injection every 2 weeks or a single injection of 420 mg/month or to sham injections.

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.




The study has focused on the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death. The difference equates to a 1.5 percentage point absolute reduction in cardiovascular outcome risk and a 15% relative reduction favoring Repatha.

Dr Marc Sabatine, from Brigham and Women's Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology's (ACC) 66th Annual Scientific Session in Washington. The study was also published Friday in the New England Journal of Medicine.

Bad cholesterol is the main culprit in the heart world. On this measure, Repatha performed better, showing a 20% relative risk reduction compared to placebo.

An global trial of 27,000 patients found that those who took the drug evolocumab saw their bad cholesterol levels fall by around 60% on average.

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

Longer term, Sabatine said, there could be a reduction in deaths as well.

"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".

However, most of the patients who require the drug can not afford it because it costs a whopping $ 14,523 every year.

Weiss, the UCSF cardiologist, takes issue with Amgen's interpretation of the Repatha data. "You don't get to cherry pick the results you like", he said. With the detailed results now in hand, JP Morgan views that latter point as the most important variable in the coming months.

Current plans restrict use of Repatha through both onerous utilization criteria and a bureaucratic process that results in doctors giving up on writing a script.

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