Amgen: Evolocumab In Combination With Statin Therapy Reduces LDL Cholesterol

(RTTNews) - Amgen (AMGN) announced the publication of data from the Phase 3 LAPLACE-2 (LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2) study. Results from the 12-week study, which evaluated 1,896 patients with high cholesterol, showed treatment with subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) in combination with different daily doses of statin therapy significantly reduced mean low-density lipoprotein cholesterol (LDL-C) regardless of statin dose. Evolocumab reduced mean LDL-C by 55-76 percent from baseline compared to placebo and 38-47 percent from baseline compared to ezetimibe.

"Results from the Phase 3 LAPLACE-2 study show that evolocumab provided cholesterol-lowering regardless of statin therapy and we look forward to bringing this new treatment option to patients who are taking statins and still need additional treatment options to lower their cholesterol levels. These results in combination with data from other studies in our clinical trial program form the basis of our global filing plan for evolocumab and we are working closely with regulatory authorities to provide this treatment to patients with high cholesterol," said Sean Harper, M.D., executive vice president of Research and Development at Amgen.

Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove LDL-C from the blood.