Amgen Tanks On Heart-Study; Shares Of Other Drugmakers Tumble

Jeannette Daniel
March 21, 2017

"So we expect that this drug also will be embraced by the medical community" and incorporated into clinical guidelines, Levy said.

Evolocumab reduced low-density lipoprotein (LDL), or "bad" cholesterol, by 59 percent.

Some patients who are unable to take traditional cholesterol-lowering drugs known as statins, due to their side effects, may be able to take PCSK9 inhibitors instead. All of them were already receiving statin therapy. The patients were randomized to receive injections of Repatha every two weeks or once monthly, or a matching placebo injection. They followed-up these people for two years, from 2013 to 2015.

The drug had no effect on CV death when measured separately-the heart attack and stroke numbers included fatal episodes-and no effect on angina hospitalizations, and a 22% reduction in risk for revascularization procedures. The researchers found an average decline of 59 percent in LDL levels among the 14,000 people in 49 countries who were put on the drug for 48 weeks, when compared with an nearly identical number of patients who received a placebo.

And the FDA approved evolocumab, made by Amgen in Thousand Oaks, California, only for certain patients, such as those with a hereditary condition that causes extremely high levels of LDL.

In the study, also published in The New England Journal of Medicine, 5.9 percent of patients who combined Repatha with a statin had a heart attack, stroke or died, compared with 7.4 percent of patients who took a statin plus a placebo.

The results should loosen the purse strings of insurers reluctant to pay for a drug with a list price of over $14,000 a year before discounts, given the high cost of treating strokes and heart attacks.

The Fourier trial tested Repatha in patients at high risk of a cardiovascular event, a group in which Amgen sees a high unmet need, with no real advances in treatment in more than a decade.

But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins.

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But it comes at a hefty price tag of more than $14,000 per year, raising concerns about how many patients could benefit.

This treatment has not been approved for all kind of patients. "Creating new treatments which use this approach could prove life-saving for patients with high cholesterol and those who can't tolerate statins".

Those benefits are clinically significant, not just statistically significant, and in a conference call hosted by Mizuho Securities USA Inc.'s senior biotech analyst Salim Syed, James Underberg, a clinical assistant professor of medicine at New York University Medical School and president-elect of the national lipid association, stressed the good news about the results.

"The data from our trial provide insight into the benefit of decreasing LDL cholesterol levels to median levels lower than those in previous trials", wrote the researchers, led by Marc S. Sabatine of Brigham and Women's Hospital in Boston.

According to the Centers for Disease Control and Prevention, around 610,000 people die each year in the United States as a outcome of heart disease.

The drugs work by blocking a protein that affects the liver's ability to remove cholesterol from the blood.

There were three secondary endpoints; changes in working memory, memory function and psychomotor speed. This investigation was also presented in the American College of Cardiology meeting. "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", stated Sean E. Harper, M.D., EVP of R&D at Amgen.

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.

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