Amgen has received approval for review from US Food and Drug Administration (FDA) for its evolocumab to treat high cholesterol.
The FDA accepted Biologics License Application (BLA) for evolocumab, an investigational fully human monoclonal antibody that inhibits proproteinconvertasesubtilisin/kexin type 9 (PCSK9).
PCSK9 is a protein, which reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C) or bad cholesterol from the blood.
Amgen research and development executive vice-president Sean Harper said: “There is still a large unmet need among patients with high cardiovascular risk and elevated cholesterol who are unable to reach optimal LDL cholesterol levels with current therapies.
“Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol.”
The BLA was based on data from 6,800 patients, including more than 4,500 patients with high cholesterol in ten Phase III trials.
Studies assessed the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies and patients who cannot tolerate statins.
In addition, the study evaluated the drug in patients with heterozygous familial hypercholesterolemia (HeFH) and patients with homozygous familial hypercholesterolemia (HoFH).
For the evolocumab application, the FDA set a Prescription Drug User Fee Act (PDUFA) target action date of 27 August 2015.
