Results of Phase 3 HUYGENS study of Amgen's PCSK9 inhibitor cholesterol-lowering drugs announced

Amgen recently announced the PCSK9 inhibitor class of new cholesterol-lowering drug Repatha (Repatha®, generic name: generic name: ilocumab, evolocumab) at the 2021 European Society of Cardiology (ESC) conference.
Positive results of the HUYGENS study
.

The data shows that in patients with coronary artery disease (CAD), Repatha combined with optimized statin therapy significantly improved the stability of plaque compared to optimized statin therapy

A heart attack is usually the result of a rupture of a vulnerable plaque
.

The main feature of vulnerable plaque is a large lipid core with a thin fibrous cap that acts as a wall or barrier around the plaque to keep the plaque intact

The HUYGENS study reached its primary endpoint: using optical coherence tomography (OCT) measurement, Repatha combined with optimized statin therapy significantly increased the thickness of the fiber cap (increase: 42.
7um vs 21.
5) compared with optimized statin therapy alone.
um; increase rate: 75% vs 39%; p=0.
01)
.

Therefore, compared with the statin therapy alone, the addition of Repatha improves this feature twice as much as the former

A 52-week randomized, double-blind study of patients with acute coronary syndrome (ACS) receiving optimized statin therapy showed that starting Repatha treatment within one week of the ACS event can reduce LDL-C from 140 mg/dL To 28 mg/dL (-80%), and the use of statins alone can reduce LDL-C from 142 mg/dL to 87 mg/dL (-39%)
.

No new security risks were found in the research

Most Acute Coronary Syndrome (ACS) events are caused by plaque rupture.
Heart attack patients are particularly prone to additional plaque rupture, which indicates the importance of maintaining the thickness of the fibrous cap to help stabilize the plaque
.

Plaque stability

Previous studies, including the GLAGOV study, have shown that when added to optimized statin therapy, Repatha can reduce plaque burden by reducing plaque volume in CAD patients
.

This is the first study to prove that reducing LDL-C levels by inhibiting PCSK9 can reduce plaque burden

The HUYGENS study shows that: Compared with optimized statin therapy, Repatha combined with optimized statin therapy significantly improves the plaque stability of CAD patients by increasing the thickness of the fibrous cap
.

The HUYGENS study may provide mechanistic insights into the reduction of CV events in the FOURIER outcome study

Although the HUYGENS study did not evaluate cardiovascular outcomes, the results of the study are based on more and more evidence, which already supports the clinical characteristics of Repatha
.

The results of the HUYGENS study add relevant insights to the science of plaque biology and help understand the important benefits of initiating Repatha treatment after a heart attack

Repatha is a human monoclonal immunoglobulin G2 (IgG2) directed against the human proprotein convertase subtilisin kexin type 9 (PCSK9)
.

The drug binds to PCSK9 and inhibits the binding of circulating PCSK9 to low-density lipoprotein (LDL) receptors (LDLR), thereby preventing PCSK9-mediated degradation of LDLR, allowing LDLR to recirculate back to the surface of liver cells

Up to now, Repatha has been approved in 76 countries and regions, including all 27 member states of the United States, Japan, China, and the European Union
.
Applications in other countries are currently in progress
.

In China, Repatha (Generic Name: Generic Name: Iloyuumab, evolocumab) was first approved in August 2018, becoming the first treatment for homozygous familial high cholesterol in adults or adolescents over 12 years old PCSK9 inhibitor of HoFH
.
In January 2019, Repatha was approved for a new indication: it is used in adult patients with atherosclerotic cardiovascular disease (ASCVD) to reduce the risk of myocardial infarction, stroke and coronary revascularization
.
This approval makes Repatha the first PCSK9 inhibitor in the Chinese market that can be used for this indication
.

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Original Source: New Data At ESC Congress 2021 Shows Repatha? (evolocumab) Improves Features Of Plaque Stability In Patients With Acute Coronary Syndrome (ACS)