Initial results from Amgen’s FOURIER clinical trial show that Repatha reduces the risk of cardiovascular events in patients with heart disease. According to a press release issued by the drugmaker, more detailed results of the study will be presented at the American College of Cardiology (ACC) 66th Annual Scientific Session.
Along with reducing the risk of heart attacks, strokes and death in patients, the cholesterol-lowering PCSK9 inhibitor was on-par with the placebo in terms of its effect on cognitive function. As rare instances of neurocognitive events have occurred in some late-stage PCSK9 clinical trials, these findings help ease concerns that the drug could impair cognition.
Amgen’s previous study – the GLAGOV trial – demonstrated Repatha’s ability to reduce atherosclerosis by lowering cholesterol. The current trial did not uncover any previously-unknown safety issues associated with Repatha.
“These FOURIER results show unequivocally the connection between lowering LDL cholesterol with Repatha and cardiovascular risk reduction, even in a population already treated with optimized statin therapy,” said Dr. Sean E. Harper, executive vice president of Research and Development at Amgen. “Cardiovascular disease remains the number one health burden in the world, and we look forward to sharing these outcomes data with the scientific community at the ACC 66th Annual Scientific Session.”
The Phase III FOURIER trial involved approximately 27,500 patients who had previously experienced a heart attack, ischemic stroke or symptomatic peripheral artery disease. These patients were all on optimized statin therapy, and were randomly assigned to Repatha or a placebo injection, administered bi-weekly.
Repatha is a monoclonal antibody that inhibits the PCSK9 protein. By binding to PCSK9, Repatha prevents the protein from binding to the low-density lipoprotein (LDL) receptor (LDLR), which is responsible for removing LDL cholesterol. Repatha allows the LDLR to perform this function by removing interference from PCSK9, thereby reducing levels of LDL-C in the blood.
Cardiovascular disease is the number one cause of death globally. Approximately 11 million individuals in the US have atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) that remains uncontrolled with statins alone.