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Journal Of The American Medical Association Publishes Phase 3 LAPLACE-2 Study Showing Evolocumab Significantly Reduced LDL Cholesterol In Patients On Statins Regardless Of Statin Dose

THOUSAND OAKS, Calif., May 13, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the publication of data from the Phase 3 LAPLACE-2 ( LDL-C  Assessment with  PCSK9 Monoclona L  Antibody Inhibition  Combined with Statin Th Erapy-2) study in the Journal of the American Medical Association (JAMA). 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. These findings were initially presented at the American College of Cardiology's 63 rd Annual Scientific Session (ACC.14) in March 2014.

Evolocumab, an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood 1, reduced mean LDL-C by 55-76 percent from baseline compared to placebo and 38-47 percent from baseline compared to ezetimibe ( p<0.001). No adverse events (AEs) occurred in  > 2 percent of the evolocumab combined group. The most common AEs in the evolocumab combined group were back pain, arthralgia, headache, muscle spasms and pain in extremity.

"Elevated LDL cholesterol is recognized as a major risk factor for cardiovascular disease, and although statins are effective in reducing LDL cholesterol levels, many patients may need additional LDL cholesterol lowering," said lead investigator Jennifer G. Robinson, M.D., M.P.H., director of the Prevention Intervention Center, professor of the Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "This is the first study to demonstrate that the addition of evolocumab results in similar percent reductions in LDL cholesterol and achieved LDL cholesterol levels regardless of stable baseline statin type, dose or intensity, across three commonly prescribed statins and a broad range of doses."

There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe. 2 According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C 3, or "bad" cholesterol, and elevated LDL-C is recognized as a major risk factor for cardiovascular disease. 4,5

"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," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "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."

LAPLACE-2 Study DesignLAPLACE-2 ( LDL-C  Assessment with  PCSK9 Monoclona L  Antibody Inhibition  Combined with  Statin Th Erapy-2) is a Phase 3 randomized, multicenter, double-blind, placebo- and ezetimibe-controlled study designed to evaluate safety, tolerability and efficacy of evolocumab in 1,896 patients with primary hypercholesterolemia and mixed dyslipidemia (LDL-C ≥80 mg/dL) when added to statin therapy. Patients were randomized to one of 24 treatment groups in a two-step randomization. Eligible patients were initially randomized to one of five open label background statin treatments: atorvastatin 10 mg, atorvastatin 80 mg, rosuvastatin 5 mg, rosuvastatin 40 mg or simvastatin 40 mg daily. Patients randomized to atorvastatin were then randomized to one of six treatment groups: evolocumab every two weeks and oral placebo, evolocumab every month and oral placebo, subcutaneous placebo every two weeks and oral placebo, subcutaneous placebo every month and oral placebo, subcutaneous placebo every two weeks and ezetimibe 10 mg, or subcutaneous placebo every month and ezetimibe 10 mg. Patients randomized to rosuvastatin or simvastatin were then randomized to one of four treatment groups: evolocumab every two weeks, evolocumab every month, subcutaneous placebo every two weeks, or subcutaneous placebo every month.

The co-primary endpoints were the mean percent change from baseline in LDL-C at weeks 10 and 12 and the percent change in LDL-C reduction at week 12. Co-secondary efficacy endpoints included means at weeks 10 and 12 and at week 12 for the following: LDL-C <70 mg/dL; absolute change from baseline in LDL-C; and the percentage change from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol (TC)/HDL-C ratio, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a), triglycerides, HDL-C and very low-density lipoprotein cholesterol (VLDL-C).

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