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

A long-acting cholesterol medicine cut the risk of having a heart attack or some other serious problems by 15 to 20 percent in a big study that's likely to spur fresh debate about what drugs should cost. People with naturally occurring mutations in the PCSK9 gene have unusually low levels of bad cholesterol - and up to an 88% lower risk of developing heart disease.

Inclisiran, a PCSK9 synthesis inhibitor created to lower cholesterol levels in the blood, was shown to significantly lower low-density lipoprotein cholesterol (LDL-C) while maintaining standards of safety and tolerability for every single patient in a clinical trial, a triumph in treatment for cardiovascular disease caused by high cholesterol.

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.

In the study, published today in the New England Journal of Medicine, researchers looked at the protective effect of evolocumab on patients in 49 countries, with a history of atherosclerotic vascular disease, who were already taking statins to reduce their cholesterol.

The global team, which includes researchers from Imperial College London, says the drug could provide added benefit to patients already taking statins by further reducing the levels of low-density lipoprotein (LDL) cholesterol in their blood.

The trial was statistically powered around the "hard" major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke, or cardiovascular death (the key secondary composite endpoint) and found that adding evolocumab to optimized statin therapy resulted in a statistically significant (P 0.001) 20% reduction in those events.

The FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) trial--a multinational, phase 3, randomized, double-blind, placebo-controlled study--was created to evaluate whether treatment with evolocumab in combination with statin therapy compared with placebo plus statin therapy reduces cardiovascular events. "There are a lot of people already on optimal doses of statins who have levels of cholesterol that could be lowered further", explained Professor Sever.

After about two years, Repatha, used along with statins, reduced LDL from a median of 92 to 30.

Patients treated with evolocumab experienced a 27% reduction in the risk of heart attack (P 0.001), a 21% reduction in the risk of stroke (P = 0.01), and a 22% reduction in the risk of coronary revascularization (P 0.001) compared with those given placebo. Almost 10 percent of folks on Repatha had one versus more than 11 percent on the dummy drug. "I don't think so".

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

Amgen said it is taking steps to remove barriers to patient access, including a plan under which it would offer to refund Repatha costs for eligible patients who have a heart attack or stroke.

The researchers hope that with more time, they can show Repatha can prevent early deaths.

Bococizumab significantly reduces cardiovascular events in high-risk patients with high LDL cholesterol levels. But it's still unclear whether these drugs - which attempt to mimic a beneficial genetic mutation - will be the breakthrough that scientists and pharmaceutical companies had imagined.

A study testing whether Praluent also lowers heart risks will wrap up later this year.

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