FDA accepts to review Amgen’s BLA for LDL cholesterol-lowering drug evolocumab

Evolocumab inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C) or bad cholesterol from the blood.

The BLA was based on data secured from about 6,800 patients, including more than 4,500 patients with high cholesterol in ten Phase III trials.

These trials assessed the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies; patients who cannot tolerate statins; patients with heterozygous familial hypercholesterolemia (HeFH); and patients with homozygous familial hypercholesterolemia (HoFH).

Amgen executive vice-president of Research and Development 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."

For the evolocumab application, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 27 August 2015.

Elevated LDL-C is the most common form of dyslipidemia, which is an abnormality of cholesterol and/or fats in the blood, while it is recognized as a major risk factor for cardiovascular disease.

Familial hypercholesterolemia (FH) is an inherited condition caused by genetic mutations that lead to high levels of LDL-C at an early age.

Image: Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.