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news.Amgen has reported positive 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 trials of Repatha (evolocumab).
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Repatha is a new investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication.
A total of 4,465 patients were enrolled in the trial who had completed one of 12 Phase II and III Repatha trials, 2,976 of whom were randomized to subcutaneous Repatha 140mg every two weeks or 420mg monthly plus standard of care (SOC) therapy and 1,489 were randomized to SOC alone over one year.
At parent study baseline, the median LDL-C was 120mg/dL and around 70% of patients were on a statin at the start of the extension trials.
One-year data from these ongoing trials showed that Repatha plus SOC treatment reduced adjudicated cardiovascular events.
Amgen executive vice president of Research and Development Sean Harper said: "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.
"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."
Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that targets LDL receptors for degradation and thereby reduces the liver’s ability to remove LDL-C (bad cholesterol) from the blood.