News Feature | April 14, 2014

Amgen's Experimental Drug Can Lower LDL Cholesterol By Up To 66 Percent

By Marcus Johnson

Three studies of Amgen’s experimental drug evolocumab, which belongs to the PCSK9 inhibitors class, were presented in the American College of Cardiology conference late last month. The drug, which blocks a protein that reduces the liver’s ability to remove LDL from the blood, was found in three late-stage clinical trials to lower LDL cholesterol by as much as 66 percent. In a previous series of five late-stage trials involving over 4,000 patients, Amgen said evolocumab significantly outperformed placebo and other cholesterol medications.

The three recent Amgen studies involved 2,000 patients who took the company’s drug for up to a year’s time. As many as 70 million Americans have high LDL cholesterol, which puts them at risk for heart disease and a host of other cardiovascular problems. The new evolocumab drug is considered to be a new treatment option for people who have had difficulties lowering their cholesterol using Liptor or other statin drugs. Several other companies are also developing drugs similar to Amgen’s, including Regeneron Pharmaceuticals and Pfizer.

Amgen is expected to file a drug application for evolocumab later this year, Reuters says, and industry analysts believe that the drug could haul in more than $3 billion a year in sales.

Although Amgen has proven to be successful at lowering cholesterol,  many doctors still want to see if the process by which the drug lowers cholesterol will ultimately lead to fewer heart attacks and cardiovascular events. Zetia, a cholesterol drug which has declined in use since 2008, was proven to lower cholesterol, but was not successful at preventing heart attacks. Dr. Hadley Wilson, a cardiologist at Carolina’s HealthCare System, believes that evolocumab should be approved just based on its ability to lower cholesterol. “We need additional agents other than statins’ to help patients,” he said.