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Amgen's Repatha lowers heart attack, stroke risk in phase 3 study

PBR Staff Writer Published 20 March 2017

A phase 3 study has demonstrated that Amgen’s cholesterol drug Repatha reduces low-density lipoprotein cholesterol (LDL-C) levels and risk of cardiovascular events.

The trial demonstrated that Repatha has maximum reduced low-density lipoprotein cholesterol (LDL-C) levels, helping to decrease the risk of major cardiovascular events such as heart attacks, strokes and coronary revascularizations.

Repatha is a human monoclonal antibody, which supressess proprotein convertase subtilisin/kexin type 9 (PCSK9).

The study has focused on the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death.

It demonstrated that adding Repatha to enhance statin therapy resulted in a statistically significant 20% reduction in these events

Repatha decreased LDL-C from a median of 92 to 30 mg/dL when added to statin therapy, showing a reduction of 59% at week 48 that was continued across the trial.

Amgen’s scientists have developed Repatha by interacting PCSK9 and the LDL receptor (LDLR), including the site where the LDLR binds to PCSK9. They developed antibodies that bind to PCSK9 at that site and block the interaction of PCSK9 with the LDLR.

According to the company, the trail’s primary endpoint is the time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization, while the secondary endpoint is the time to cardiovascular death, myocardial infarction or stroke. 

Amgen research and development executive vice president Dr Sean Harper said: “This is a game changer for high-risk patients. Even though these patients were optimally treated with the latest therapies, they were still at high risk for an additional cardiac event.

“It’s remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years.”


Image: Amgen’s Repatha (evolocumab). Photo: courtesy of Amgen.