Amgen Publishes Safety Analysis Of Investigational Cholesterol-Lowering Medication Repatha

Amgen has announced one-year data from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase II (OSLER-1) and Phase III (OSLER-2) open-label extension studies of Repatha (evolocumab), a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication. These data were presented at a Late-Breaking Clinical Trial session at the American College of Cardiology's 64th Annual Scientific Session (ACC.15) and published in the New England Journal of Medicine. A 2-year analysis of Repatha safety and tolerability data from the longest proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor trial to date (OSLER-1) was also presented.

Data from prespecified exploratory endpoints in the ongoing open-label OSLER-1 and OSLER-2 studies showed Repatha plus standard of care (SOC) treatment reduced adjudicated cardiovascular events (0.95 percent Repatha plus SOC; 2.18% SOC) over a one-year analysis period. Adverse events (AEs) (=1% in the Repatha plus SOC group and more frequent in the Repatha plus SOC group by at least 1%) included arthralgia, headache, pain in extremity and fatigue. The cardiovascular events analysis comprises exploratory findings from the ongoing open-label OSLER studies. Repatha plus SOC treatment reduced LDL-C by 61% compared to SOC.

"We are excited to present several data analyses at ACC.15 from the Repatha clinical trial program, including an analysis of cardiovascular events and safety data from the longest PCSK9 inhibitor trial to date," said Sean E. Harper, executive vice president of R&D at Amgen. "The clinical data are encouraging, and we look forward to seeing the results from our cardiovascular outcomes trial, FOURIER, which was designed to investigate whether there is a substantial reduction in the occurrence of major cardiovascular events with the use of Repatha. We continue to work with regulatory agencies to make Repatha available to patients."