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Amgen Announces Evolocumab (AMG 145) Results From First 52-Week Study Of A PCSK9 Inhibitor To Reduce LDL Cholesterol
Date:11/19/2013

rapy for Easing Lipid Levels) in patients who were not receiving statin therapy.

– LAPLACE-TIMI 57 (LDL-C Assessment With PCSK9 MonoclonaL Antibody Inhibition Combined With Statin ThErapy – Thrombolysis In Myocardial Infarction-57) in patients on statin therapy.

– RUTHERFORD (RedUction of LDL-C With PCSK9 InhibiTion in HEteRozygous Familial HyperchOlesteRolemia Disorder Study) in patients with heterozygous familial hypercholesterolemia.

– GAUSS (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) in statin-intolerant patients.

A total of 1,104 patients enrolled in the OSLER extension study. Patients were randomized 2:1 to receive evolocumab subcutaneously at 420 mg monthly with SOC or SOC alone for one year. The primary objective was to evaluate the safety and tolerability of evolocumab on a background of SOC. Secondary objectives were effects on lipid parameters compared to Phase 2 study baseline levels.

About PROFICIO: The Evolocumab Clinical Trial Program
PROFICIO, which stands for the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations, is a large and comprehensive clinical trial program evaluating evolocumab. Phase 3 clinical trials for evolocumab are currently underway and build upon the Phase 2 studies.

The Phase 3 program includes 13 trials, with a combined planned enrollment of more than 28,000 patients. The Phase 3 studies will evaluate evolocumab administered every two weeks and monthly in multiple patient populations, including in combination with statins in patients with hyperlipidemia (LAPLACE-2), in patients with hyperlipidemia who cannot tolerate sta
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