Amgen cholesterol injection Repatha (evolocumab) has been demonstrated to have cut heart attack and stroke risk by 20% in a phase 3 cardiovascular outcomes study featuring 27,564 patients with heart diseases.
Amgen Cholesterol Trial for Repatha Cholesterol Injection
During the trial, it was proven that by maximum reduction of low-density lipoprotein cholesterol (LDL-C) levels (bad cholesterol) with Repatha cholesterol injection, more than the levels that are reduced with the best therapy around at the time, resulted in a further decrease in major cardiovascular events like heart attacks, coronary revascularizations and strokes. Besides, there were no new safety issues in the Amgen cholesterol trial.
The phase 3 study named as FOURIER was evaluating Amgen’s cholesterol treatment with Repatha injection in combination with statin therapy against placebo plus statin therapy in the reduction of cardiovascular events.
Patients participating in the phase 3 trial of the Amgen cholesterol injection were either having high cholesterol or non-high-density lipoprotein cholesterol, and having clinically evident atherosclerotic cardiovascular disease.
At more than 1,200 clinical sites across the world, one patient group in the trial was subjected to 140mg Repatha injection subcutaneously once in two weeks or 420mg once in a month along with optimized statin dose. The other group was given 140mg placebo subcutaneous injection once in two weeks or 420mg once in a month along with effective statin dose.
Amgen Cholesterol Injection Repatha Primary Endpoint and Secondary Endpoints
FOURIER’s primary endpoint is the time to cardiovascular death, heart attack, stroke, hospitalization for unstable angina, or coronary revascularization. The important secondary endpoint is the time to cardiovascular death, heart attack or stroke.
The Repatha patient group had their risk of heart attack come down by 27%, stroke by 21% and coronary revascularization by 22%. In line with recent studies, the phase 3 Amgen cholesterol trial of the Repatha injection, there was no observed impact of intensive LDL lowering on cardiovascular mortality.
Likewise, there was no impact observed on hospitalization for unstable angina during the phase 3 Amgen cholesterol study of Repatha injection. According to the pharma, an exploratory analysis showed that the associated risk for fatal and non-fatal heart attack or stroke had come down to 19% in the first year, and 33% after the first year with the Repatha cholesterol injection plus statin therapy.
Amgen Comments on Repatha Cholesterol Injection Trial Results
Sean E. Harper, M.D., executive vice president of Research and Development at Amgen called the results of the phase 3 trial of the company’s cholesterol injection, Repatha as a game changer for patients at high risk.
As per Harper, although the patients in the trial received optimum treatment with the most recent therapies, an additional cardiac event was highly possible in them.
Sean E. Harper added: “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.”
“The absolute benefit will be even greater than what we observed in the Repatha outcomes trial, since the cardiovascular event rate in clinical practice is about 2-3 times higher than what is typically reported in a rigorously controlled outcomes trial.”
Mechanism of Amgen Cholesterol Injection Repatha
Repatha, a human monoclonal antibody, prevents proprotein convertase subtilisin/kexin type 9 (PCSK9). The Amgen cholesterol injection binds to the PCSK9 enzyme and prevents the latter from binding to the LDLR.
This, in turn stops PCSK9-mediated LDLR degradation and allows LDLR to recycle again to the surface of the liver cell. As per Amgen, Repatha cholesterol injection increases the availability of LDLRs to remove LDL from the blood and thus reducing the levels of LDL-C.