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. Injection site reactions were more common with Repatha than placebo, but remained at low levels.
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.
This reduction in risk improved over time, increasing from 16 per cent in the first year to 25 per cent after the first year, the researchers said. More cautious doctors insisted they needed proof that it prevents heart attacks and strokes.
"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. Statins such as Lipitor and Crestor are cheap and lower LDL or bad cholesterol, but some people can't tolerate or get enough help from them. Repatha, and the PCSK9 drug class as a whole, rode to market on high expectations ginned up by strong efficacy in lowering LDL cholesterol.
However, new drug evolocumab changes the way the liver works to also cut bad cholesterol. They followed-up these people for two years, from 2013 to 2015. "I don't think so", said Hlatky.
Those who took both were less likely to suffer a heart attack or stroke than if they took statins alone.
Underberg and Stone noted that evolocumab decreases the absolute risk of a heart attack or stroke by about 1.3 percent at two years, and 2 percent at three years. The companies also are in a patent war over the drugs.
The refunds would go to insurance companies, not patients, Ofman said. We continue to see Amgen's broad portfolio and newer drugs-including approved drugs Repatha and Kyprolis, novel pipeline therapies, and an industry-leading biosimilar pipeline-as providing a wide economic moat and a buffer to biosimilar threats to the older Enbrel and Neulasta franchises. 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.
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. That committee - 15 doctors and a pharmacist - reviews the information that federal regulators used to approve a drug and then decides whether it should be covered.
This treatment has not been approved for all kind of patients. That can limit patient access.
"It's a small reduction for a super expensive drug", said Dr. John Mandrola, a cardiologist at Baptist Health in Louisville, Ky., and chief cardiology correspondent for Medscape, who wasn't involved in the study. "It's a little more convenient for patients, potentially". Results from a similar Praluent trial are expected later this year.
Sales for the drug have been modest as payers have balked at the high price tags for Repatha and its rival Praluent (alirocumab) - developed by Sanofi and Regeneron. But once the drugmaker AbbVie produced a third option, Viekira Pak, with a similar cure rate, Express Scripts was able to negotiate a price discount and switched to covering only Viekira Pak.
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.