The drug's mechanism of action was discovered by studying people with mutations to the gene for PCSK9 that allowed them to maintain exceptionally low cholesterol levels.
According to some reports, Amgen may go even further and is considering options, such as offering a refund for any patient that has a heart attack. But use of these expensive antibodies has been rather limited while clinicians and payers alike waited for proof they actually reduce heart attacks and strokes. They were taking optimal doses of cheap, 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. All of them were already receiving statin therapy.
Patients on the trial, who continued to take statins, were chosen to randomly receive either injections of evolocumab-140 mg twice a month, or 420 mg once a month-or placebo injections. They followed-up these people for two years, from 2013 to 2015.
A new cholesterol-slashing drug that has shown promise for high-risk patients does not impair brain function, according to a study out Saturday. In contrast, in the real-world setting based on an analysis of patients in the UK CPRD database, an event rate of 12.3 (for all events) was observed.
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.
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.
Investors were expecting Repatha to show a cardiovascular risk reduction of 20-22%, so the drug's true performance in a population of higher-risk patients is a disappointment from the market's perspective. "The open question was, 'Does this way of lowering [cholesterol] reduce risk of coronary heart disease, '" says Sekar Kathiresan, a cardiologist at the Massachusetts General Hospital in Boston and the Broad Institute in Cambridge, Massachusetts, who was not involved in the study. The result? Sales of Repatha came in at $141 million past year and Praluent made around $112 million, well shy of initial expectations.
Mnuchin softens brazen U.S. trade talk in global stage debut
In a visit to Berlin ahead of the G-20 meeting, Mnuchin said the U.S.is interested in trade that is not only free but fair. But, the Trump administration is taking a protectionist stance saying it is part of an effort to save United States jobs.
This treatment has not been approved for all kind of patients. For now, "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 currently offered", said Lloyd-Jones.
However, each doctor JP Morgan spoke to remained well grounded to the realities of its healthcare system and expressed their belief that these data would result in a meaningful easing of payer restrictions, but more work needs to be done to identify higher risk patient segments.
Repatha is a human monoclonal antibody, which supressess proprotein convertase subtilisin/kexin type 9 (PCSK9).
The Amgen study, known a FOURIER, did demonstrate a statistically significant cardiovascular benefit for patients treated with Repatha, part of a new class of injected cholesterol lowering drugs known as PCSK9 inhibitors.
According to the Centers for Disease Control and Prevention, around 610,000 people die each year in the United States as a outcome of heart disease.
Amgen's scientists have developed Repatha by interacting PCSK9 and the LDL receptor (LDLR), including the site where the LDLR binds to PCSK9.
Researchers assessed the executive function, working memory, episodic memory and psychomotor speed of patients at six, 12, and 24 months after starting treatment. This investigation was also presented in the American College of Cardiology meeting.