Amgen's Repatha cardio data fails to impress

Evolocumab and clinical outcomes in patients with CVD

Amgen's Repatha cardio data fails to impress

Options on the table include a refund of the drug's cost for any eligible patient which suffers a heart attack or stroke while on the drug. Repatha and a similar drug, Praluent, called PCSK9 inhibitors, were approved in 2015 for people with inherited risk for high cholesterol, or heart disease that had already caused a problem such as a heart attack.

Dr Sabatine said: "These data show that lowering LDL cholesterol beyond current treatment targets confers significant benefits for our patients with cardiovascular disease who are at a high risk of cardiovascular events". But he called the study "a solid outcomes trial" and said "we should celebrate" that it showed the drug is capable of reducing risk.

The study conducted on the large worldwide trial on 27,000 patients indicates that the drug can be used very soon by millions of people across the world. Repatha and Praluent cost more than $14,000 a year before discounts and rebates.

Despite the positive results, Medicine Co shares fell 14.6 percent after highly-anticipated data from Amgen Inc's rival drug Repatha failed to reach investor expectations for how much it cut the risk of serious adverse heart events in data presented earlier on Friday at the American College of Cardiology (ACC) scientific meeting in Washington.

'We need to treat LDL cholesterol more aggressively, and now we have a new validated means to do so'.

There was also a statistically significant 15 per cent reduction in the risk of the extended MACE composite endpoint, which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death. Repatha is also known as evolocumab.

"As demand and use goes up, the insurance companies usually follow", Steinbaum said. They were taking optimal doses of inexpensive, cholesterol-lowering statins, which gave them an average LDL of 92, well within the range - an LDL of under 100 - that has been advised for high-risk patients. It was a conventional clinical trial design, in which more than 27,000 people who had previously suffered a heart attack, but who had been unable to achieve optimal LDL cholesterol with dietary advice and existing medications (including statins), were randomized to receive either evolocumab or a placebo regularly for just over 2 years. JP Morgan also had the opportunity to speak with several doctors at the conference who further confirmed its view that, while Repatha is clearly a safe and effective drug, penetration may (at least in the near term) remain confined to more advanced patients, potentially making it hard to meet prevailing commercial expectations (details below). Most trial subjects had had a prior heart attack or stroke.

While diet guides and medical textbooks aimed at the general reader aim to lower cholesterol, there is a difference, with total cholesterol, between "good" and "bad" cholesterol.

There are approximately 2.3 million people living with coronary heart disease in the United Kingdom, according to the NHS.

Anti-PCSK9 antibodies are the jewel in the crown of modern genomic medicine, illustrating what many hope will be a paradigm for future drug discovery.

Last May it was made available on the NHS for 325,000 people at high risk.

However, Prof Sever said: "They will probably not [replace statins], there are an bad lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down".

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

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