With New Data, Amgen Promises Refund If Cholesterol Drug Doesn't Work

Most had had a prior heart attack or stroke.

Not necessarily, say analysts, who reckon TMC and Alnylam can learn from experiences with the established drugs for their phase 3 program, which is due to start mid-year, and set themselves up for success. He suggests that high-risk patients, or those who can't tolerate statins, talk to their doctor about possibly taking the cholesterol drug as an alternative. Patients would receive refunds for the cholesterol drug's medical costs, but with the caveat that they need to have had a heart attack or stroke while on Repatha. On average, participants in the Fourier study were 69 years old and more than two-thirds were taking moderate statins to lower cholesterol. All of them were already receiving statin therapy. They followed-up these people for two years, from 2013 to 2015.

This alternative analysis - not included in the NEJM publication but presented at the cardiology conference Friday - showed Repatha reduced the risk of heart attack and stroke by 33% compared to placebo, Harper said.

The new drug called evolocumab alters the functioning of a liver to reduce the bad cholesterol levels. Instead, it had only been tested in laboratory trials.

These drugs, some of which include Crestor and Lipitor, are effective in significantly reducing the risks of heart attack and are readily available at an affordable price.

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Coronary heart disease, in which the major arteries become clogged, affects more than 2.3million people in Britain, and 69,000 die from heart attacks every year as a result. JP Morgan's view is that, given the data and the current payer environment, physicians will choose to reserve treatment for patients with multiple comorbidities and relatively higher LDLs than the cutoff for FOURIER ( 70mg/dL).

Cardiologists have always been taught that CV patients have three risk factors that can be handled with treatment: high blood pressure, smoking and high LDL cholesterol, Levy said.

Steve Miller, Chief Medical Officer of Express Scripts Holding, the nation's largest PBM, said he expects doctors to begin writing more prescriptions for Repatha as soon as Monday, "and we are going to have to respond to that".

So far, PCSK9 drugs, which are monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9, haven't made the splash in the market that pharma watchers had expected and their makers had hoped.

In the new study, patients with heart disease who combined Repatha with a statin, the most commonly used cholesterol medication, decreased their LDL from 92 milligrams per deciliter to 30.

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

Inclisiran belongs to a new class of medicines that block a protein known as PCSK9, which prevents the removal of LDL from the blood.

Sabatine reported grants from Abbott Laboratories, Critical Diagnostics, Daiichi-Sankyo, Eisai, GlaxoSmithKline, RocheDiagnostics, Takeda, Gilead, Poxel, Novartis, Janssen Research Development, and Genzyme, grants and personal fees from Amgen, AstraZeneca, Intarcia, Merck, and MedImmune, and personal fees from CVS Caremark, Alnylam, Ionis, Cubist, Esperion, The Medicines Company, MyoKardia, and Zeus Scientific, outside the submitted work.

Researchers assessed the executive function, working memory, episodic memory and psychomotor speed of patients at six, 12, and 24 months after starting treatment.

Result of study involving Repatha were shared on Friday at a meeting of the American College of Cardiology.

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"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".