Therapy Areas: Cardiovascular
Amgen Reports Results of Sub-Study Using Virtual Histology to Evaluate Effect of Repatha (Evolocumab) on Plaque Composition
31 August 2017 - - Thousand Oaks, California-based human therapeutics developer Amgen (NASDAQ: AMGN) presented results from an exploratory virtual histology sub-study of the Repatha (evolocumab) GLAGOV Phase 3 coronary intravascular ultrasound imaging trial that looked at coronary artery plaque composition at the European Society of Cardiology Congress 2017 in Barcelona, Spain, the company said.
This sub-study included 331 patients enrolled in the GLAGOV trial and explored whether Repatha produced changes in individual plaque components (dense calcium, fibrous, fibrofatty, necrotic core) compared to placebo using virtual histology.
While virtual histology demonstrated an increase in dense calcium in coronary artery plaques in both the statin and Repatha arms, it did not detect a statistically significant difference between the two treatment groups.
However, the observed directional trend in increased dense calcium with corresponding reduction in low-density lipoprotein cholesterol (LDL-C) is consistent with findings from previous statin studies. 
GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) was a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial designed to evaluate the effect of Repatha on the change in burden of coronary artery disease in 968 patients undergoing clinically indicated coronary angiogram and on optimized background statin therapy.
Repatha (evolocumab) is a human monoclonal antibody that binds to proprotein convertase subtilisin/kexin type 9 (PCSK9) and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor, preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface.
By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
It is approved in more than 50 countries, including the US, Japan, Canada, and in all 28 countries that are members of the European Union. Applications in other countries are pending.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.


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