FDA Accepts Amgen's Application for Cholesterol-Lowering Agent

November 10, 2014
Meghan Ross, Associate Editor

The FDA is taking a look at Amgen's Biologics License Application for evolocumab.

Patients with high cholesterol may soon see a new cholesterol-lowering treatment option, as the FDA is taking a look at Amgen’s Biologics License Application (BLA) for evolocumab.

Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein responsible for hurting the liver’s ability to get rid of low-density lipoprotein cholesterol (LDL-C) from the blood, according to an Amgen press release.

Amgen’s BLA included data from close to 7000 patients, including 4500 with high cholesterol. The phase 3 studies examined the safety and efficacy of the drug in several kinds of patients, including those with elevated cholesterol on statins with or without other lipid-lowering therapies, those who cannot tolerate statins, and those with heterozygous or homozygous familial hypercholesterolemia.

“Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol,” said Sean E. Harper, MD, executive vice president of research and development at Amgen.

The FDA is expected to act on the evolocumab application on August 27, 2015.