Positive Phase III results for Amgen’s Repatha for coronary artery disease

pharmafile | September 21, 2016 | News story | Research and Development Amgen, Phase III trial, Repatha 

Amgen has announced that its monoclonal antibody Repatha (evolocumab) achieved positive Phase III results for the treatment of coronary artery disease (CAD), meeting its primary and secondary endpoints.

GLAGOV, the large serial coronary intravascular imaging trial, was designed to test whether treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha modifies atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimised statin therapy.  

“We are pleased with the positive results of this landmark study showing that Repatha modifies the underlying process of atherosclerosis,” said Sean Harper, executive vice president of Research and Development at Amgen. “We strongly believe in the potential of Repatha to aid in the fight against cardiovascular disease, and we are excited to share these data with the scientific community at the AHA Scientific Sessions.”

Cardiovascular disease is the leading cause of death worldwide, with approximately 11 million people suffering with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) who have uncontrolled levels of low-density lipoprotein (LDL-C) over 70 mg/dL, despite treatment with statins or other cholesterol-lowering therapies.

“Atherosclerosis is the major underlying cause of cardiovascular disease, which remains the leading cause of death worldwide,” Harper continued. “Now one year after the FDA approved Repatha, nearly two-thirds of patients prescribed Repatha are still being denied access. We are concerned that many patients with uncontrolled LDL cholesterol levels continue to face challenges in accessing a medicine that we now know has a positive impact on plaque burden.”  

Detailed results will be presented during the upcoming American Heart Association (AHA) Scientific Sessions 2016 in November.

Matt Fellows

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