Amgen’s Repatha shows positive outcome in Phase III trial for cardiovascular disease

22nd May 2017 (Last Updated August 9th, 2019 09:29)

US-based biopharmaceutical firm Amgen has reported positive outcome for Repatha (evolocumab) in the Phase III FOURIER trial to treat patients suffering from cardiovascular disease.

Amgen’s Repatha shows positive outcome in Phase III trial for cardiovascular disease

US-based biopharmaceutical firm Amgen has reported positive outcome for Repatha (evolocumab) in the Phase III FOURIER trial to treat patients suffering from cardiovascular disease.

Repatha is a human monoclonal antibody designed to inhibit the binding of proprotein convertase subtilisin/kexin type 9 (PCSK9) to the low-density lipoprotein receptor (LDLR).

The results from analysis of subjects with the disease and patients being given maximum-intensity statin therapy indicated that the drug safely and consistently minimised the cardiovascular events.

Participants in both analyses were compared with less intense statin therapy.

The multinational, randomised, double-blind, placebo-controlled trial Phase III FOURIER trial assessed subcutaneous 140mg twice-weekly and 420mg once-monthly Repatha in 27,564 patients.

Amgen research and development executive vice-president Sean Harper said: "These results provide further evidence for patients with established cardiovascular disease who would otherwise be considered as being successfully managed to the most stringent treatment targets.

“The Repatha cardiovascular outcomes trial shows that even patients already at lower levels of baseline LDL-C are still at risk for a cardiovascular event, and the addition of Repatha can continue to safely lower these patients' cardiovascular risk by reducing their LDL-C levels beyond current targets."

"These results provide further evidence for patients with established cardiovascular disease who would otherwise be considered as being successfully managed to the most stringent treatment targets."

During the first analysis, Repatha was found to decrease the median baseline LDL-C in patients with a baseline LDL-C less than 70mg/dL.

It also reduced the risk for primary endpoint of hospitalisation, coronary revascularisation, heart attack, stroke or cardiovascular death, as well as secondary endpoint of heart attack, stroke or cardiovascular death.

In the second analysis, the drug minimised the median baseline LDL-C from 93mg/dL to 32mg/dL and risk of major cardiovascular events.


Image: Amgen's Repatha reduces cardiovascular events. Photo: courtesy of rajcreationzs via FreeDigitalPhotos.net.