The results of a two-year clinical trial on the drug sold as Repatha by Amgen Phamaceuticals that costs more than $14,000 a year were released at the American College of Cardiology annual conference in the USA capital. All the patients were taking cholesterol-lowering statins, most at high doses.
Excitement about Repatha - also called evolocumab - has been building in the past three years, with scientists predicting it could "switch off" heart disease.
The data also show similar clinical benefit with evolocumab when analyzed according to baseline LDL levels, even in patients in the lowest quartile of baseline LDL cholesterol, in whom evolocumab reduced LDL cholesterol from 73 to 22 mg/dL.
"To what extent these new results help expand the population eligible for these drugs needs careful analyses of costs versus benefits and each health authority will need to do their calculations".
Atara Biotherapeutics Inc. ( ATRA ) expects initial data from its phase I trial of autologous version of ATA188 in patients with primary and secondary progressive multiple sclerosis to be presented by its collaborating investigators at a medical conference in late April. The researchers randomized patients to receive either injections of Repatha or placebo, and followed them for 2 years to track several cardiovascular events: heart attack, stroke, death, hospitalization for blocked blood flow to the heart, and stent or bypass surgery.
It means that if all 325,000 eligible Britons were to be treated, 2,200 potentially fatal heart emergencies would be avoided every year. By inhibiting the binding of PCSK9 to LDLRs, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
The investigation concluded that patients who received the evolocumab treatment had their risk of myocardial infarction, stroke, and coronary revascularization reduced.
To compensate, Amgen had the FOURIER study analyzed to look at the Repatha benefit starting at one year, focused on just heart attacks and strokes - the two adverse outcomes doctors care most about.
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Prof Peter Sever, from Imperial College London - which led the United Kingdom branch of the study, said: "This is one of the most important trials of cholesterol-lowering since the first statin trial, published 20 years ago". Reviews of evolocumab have been mixed, with some physicians hailing the results as major progress against heart disease, while others expected more from the expensive drug.
Patients report few side effects from Repatha, which acts differently than statins and does not cause the muscle pain and weakness that some statin users experience. More than 80 percent had suffered heart attacks, and some had histories of stroke and peripheral artery disease.
The drugs, evolocumab (Repatha) and inclisiran, both work by targeting PCSK9, an enzyme that regulates the liver's ability to remove "bad" LDL cholesterol from the bloodstream. But with a high price tag, it remains to be seen who will be able to afford the drug.
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. But the evidence of a benefit is strong enough that he will discuss the drug as an option with his patients, he adds.
"The drug was safe and well-tolerated", said lead study author Marc Sabatine, chair of cardiovascular medicine at Brigham and Women's Hospital in Boston.
British Heart Foundation medical director Nilesh Samani said the trial was a significant advance.
"We should still probably reserve these for the highest-risk patients where statins are not doing a good enough job, at least at the price they are now offered", said Lloyd-Jones.