Amgen has reported positive results from its Phase III GLAGOV trial of Repatha (evolocumab) added to optimised statin therapy in treating statistically significant regression of atherosclerosis in patients with coronary artery disease (CAD).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Repatha is a human monoclonal antibody designed to inhibit proprotein convertase subtilisin / kexin type 9 (PCSK9).

It binds to PCSK9 and prevents circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR) thereby inhibiting PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface.

The inhibition of the binding of PCSK9 to LDLR increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

The Phase III multicentre, double-blind, randomised, placebo-controlled, global assessment of plaque regression with a PCSK9 antibody as measured by intravascular ultrasound (GLAGOV) trial was conducted to evaluate the efficacy of Repatha in modifying atherosclerotic plaque build-up in the coronary arteries of patients who were already receiving optimised statin therapy, as measured by intravascular ultrasound (IVUS).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Results suggested that the study achieved its primary endpoints as Repatha induced regression in percent atheroma volume (PAV), which is the proportion of arterial lumen occupied by plaque.

Additionally, Repatha resulted to plaque regression in PAV.

"One of the most compelling results from GLAGOV is the continued reduction of plaque at LDL-C levels well below commonly accepted thresholds."

South Australian Health and Medical Research Institute professor of cardiology and deputy director Stephen Nicholls said: “Based on previous studies, we did not know if GLAGOV would show additional plaque regression at LDL-C levels below 60 milligrams per decilitre (mg/dL).

“One of the most compelling results from GLAGOV is the continued reduction of plaque at LDL-C levels well below commonly accepted thresholds.”

An exploratory analysis of the study also revealed that lesser, positively adjudicated, major cardiovascular events were happening in patients receiving Repatha compared with those receiving placebo.

Amgen is also conducting the FOURIER trial, intended to determine the efficacy of Repatha added to optimised statin therapy in reducing the risk of cardiovascular events in patients with clinically evident atherosclerotic disease.

Image: Repatha inhibits binding of PCSK9 to LDLR. Photo: courtesy of Amgen.