Amgen has released details surrounding the cardiovascular outcomes study for cholesterol-lowering drug Repatha, and we don't expect to make any significant changes to our fair value estimate. There was no question that Repatha, an antibody drug developed by Amgen, could provide stunning drops in cholesterol for people who have already maxed out the benefits of decades-old statin drugs. But researchers didn't have evidence then that the drug could also protect against heart attacks or strokes.
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. 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.
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.
It shows that for every 74 people given the drug for two years alongside statins, one heart attack, stroke or death would be prevented.
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. Many doctors wondered if such low levels would be risky, causing memory problems or dementia due to a lack of cholesterol, said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, who was not involved in the new research but has led clinical trials of PCSK9 inhibitors in the past.
Amgen Inc. presented detailed data for the FOURIER cardiovascular outcomes trial of its Repatha (evolocumab) at the American College of Cardiology (ACC) annual meeting today. After diving deeper into the data, we think it will be sufficient to change treatment guidelines, and our assumptions for net USA prices-going from roughly $10,000 today to $8,000 annually over the next couple of years as payers loosen restrictions-still hold.More news: US To Ban Electronics On Certain Flights
The drugs are self-administered with an injection pen, and work by blocking PCSK9, a naturally-occurring protein that interferes with the liver's ability to remove cholesterol from the blood. Repatha was approved for people with an inherited condition that causes high LDL levels or who have underlying heart disease but haven't been able to adequately lower their LDL with statins alone.
A second study of another PCSK9 inhibitor, bococizumab, was much less successful and was terminated, they reported Friday. However, most patients can not afford the drug as it costs an astronomical $14,523 a year.
Statins are incredibly cheap in comparison, costing the NHS about £20 a year per patient. That happened to almost 6 percent of people on Repatha versus more than 7 percent on the dummy drug.
Analysts at Jefferies also think TMC's management can draw on those datasets for the design of ORION-4, which they suggest would likely involve 10-14,000 patients, have a two-year-plus follow-up and could-potentially-show a 30% reduction in cardiovascular events.
But Dr Marc Sabatine of Harvard, who led the trial, said doctors should start to target cholesterol far more aggressively. Cardiologists not associated with Amgen had flagged two key indicators to watch: rates of neurological side events (1.6 percent for evolocumab patients, 1.5 percent for statin-only), and the onset of diabetes (8.1 percent for evolocumab, 7.7 percent for statin-only).
British Heart Foundation medical director Nilesh Samani said the trial was a significant advance.