Published: Tue, March 21, 2017
Health | By Bessie Ortiz

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

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

In the study, 5.9 percent of patients who took both Repatha and a statin suffered a heart attack or stroke or died, compared with 7.4 percent of patients who took a statin and a placebo - a 20 percent reduction.

Some doctors hailed the results as major progress against heart disease.

The US Food and Drug Administration (FDA) approved evolocumab in 2015 for use in some patients with high cholesterol, based on data showing that the drug could lower levels of "bad" low-density lipoprotein (LDL) cholesterol circulating in the blood by approximately 60%.

Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70. But any new cholesterol drug faces stiff competition from cheaper statins, which have been used to control LDL levels for decades.

"The end result was cholesterol levels came down and down and down, and we've seen cholesterol levels lower than we have ever seen before in the practice of medicine".

But Harvard's Dr Marc Sabatine, who led the trial, said high cholesterol must be treated "more aggressively, and now we have a new validated means to do so".

As Amgen reveals, the study was statistically powered around the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death. In a study conducted by Amgen 27,000 patients were observed. =============================== How do insurance companies decide what medicines to pay for and when to pay for them?

They found 34.7% of prescriptions were abandoned by the patients.

In addition, Amgen noted that there was no statistical difference between Repatha and placebo on the other cognitive domains tested: working memory, memory function and psychomotor speed - the secondary endpoints.

The offer is "a fig leaf covering a massive price", said Dr. Peter Bach, director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center in NY. These events include sudden heart death, heart attack, stroke, hospitalization for angina, or surgery to reopen a blocked artery. This investigation was also presented in the American College of Cardiology meeting. "Why not just reduce the price of the drug and make it more broadly available?" And now, Amgen plans to offer a money-back guarantee to payers in hopes of revving up the lagging lauch.

The patients in the study were already consuming statins and yet their risk was decreased further with the help of this the new therapy. For every 200 people treated with Repatha for roughly two years, three fewer people would suffer a heart attack, stroke or heart-related death.

The study involved 27,564 men and women.

However, Repatha is priced prohibitively expensive - a one-year supply runs $14,523 - and many insurance companies will not cover the drug without evidence it protects against heart attack and stroke in high risk patients.

Added to that, another study has found that more than a third of patients don't stick to treatment with the current drugs, which are given at least once a month.

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. They then could wait up to six months before needing another shot. A similar drug to Repatha, called Praluent, costs about as much.

By comparison, inclisiran is a next-generation PCSK9 inhibitor that works by reducing the ability of the liver to produce the enzyme, explained lead researcher Dr. Kausik Ray, a cardiologist at Imperial College London, in the United Kingdom. Chair of cardiovascular medicine, Dr. Steven Nissen also gave his inputs on Repatha.

About 11 million Americans could be eligible for Repatha, according to Amgen. Seventy-three per cent of these patients were already taking statins, and 31 per cent were taking ezetimibe. They cost more than $80,000 for a course of treatment, but the drugs essentially cure a debilitating disease and they had no competition.

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