News Feature | April 1, 2014

Amgen Reports New Positive Data For Evolocumab

By Estel Grace Masangkay

Amgen reported new data from two Phase III pivotal studies demonstrating cholesterol lowering drug Evolocumab’s significant reduction of LDL-C in patients on statins, as well as those who are statin intolerant.

High cholesterol is one of the most common forms of dyslipidemia, a lipid abnormality in the blood. There are an estimated 300 million cases of dyslipidemia in the U.S., Japan, and Western Europe. Over 71 million patients in the U.S. have elevated LDL-C, a recognized major risk for cardiovascular disease.

Evolocumab is an investigational, fully human monoclonal antibody designed to inhibit PCSK9 (proprotein convertase subtilisin/kexin type 9), a protein that affects and decreases the liver's ability to remove LDL-C from the blood.

Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said, “As treatment with statins continues to be an important tool in the management of high cholesterol, we are encouraged by the positive data from the Phase 3 studies of evolocumab in patients with statin intolerance and in patients already on statin therapy. We hope that evolocumab will be able to help patients who are on a moderate or high-intensity statin and not adequately controlled, as well as patients who cannot tolerate statins and are in need of an alternate treatment option to help lower their LDL cholesterol levels.”

The drug was evaluated in the two Phase III studies GAUSS-2 and LAPLACE-2, where Evolocumab showed significant reduction of LDL-C in patients from baseline compared to ezetimibe.

“Data from the GAUSS-2 study suggest evolocumab could be a promising lipid-lowering treatment for patients with high cholesterol who cannot tolerate effective doses of statins. The GAUSS-2 results are encouraging for these patients who are in need of effective lipid-lowering treatment options,” said GAUSS-2 lead investigator Erik S.G. Stroes, M.D., chair and professor of the Department of Vascular Medicine at the Academic Medical Center (AMC), Amsterdam.

Positive data from the GAUSS-2 study were published in the Journal of the American College of Cardiology (ACC). Results from two separate Phase III studies of Evolocumab were presented in late-breaking clinical trials session at ACC.14.