Amgen (AMGN) Announces Repatha Phase 3 GLAGOV Trial Met Primary, Secondary Endpoints
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Amgen (Nasdaq: AMGN) announced that the Phase 3 GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) trial evaluating the effect of Repatha® (evolocumab) on coronary artery disease (CAD) met its primary and secondary endpoints. The GLAGOV study is a large serial coronary intravascular imaging trial 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 optimized statin therapy.
Detailed results from the Phase 3 GLAGOV trial will be presented during the upcoming American Heart Association (AHA) Scientific Sessions 2016 on Tuesday, Nov. 15, 2016, between 10:45 a.m. - noon CST.
"We are pleased with the positive results of this landmark study showing that Repatha modifies the underlying process of atherosclerosis," said Sean E. Harper, M.D., 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."
GLAGOV is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial evaluating the impact of Repatha, a PCSK9 inhibitor, on coronary atheroma volume in 968 patients with CAD receiving optimized statin therapy and undergoing coronary catheterization. Patients were randomized to receive either monthly Repatha 420 mg or placebo subcutaneous injections.
No new safety concerns were identified in the GLAGOV trial. The incidence of treatment-emergent adverse events was comparable among both groups.
Harper continued, "Atherosclerosis is the major underlying cause of cardiovascular disease, which remains the leading cause of death worldwide. 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."
Cardiovascular disease is the leading cause of death worldwide.1 In the U.S., there are approximately 11 million people 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.2,3 More than 60 percent of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other currently approved lipid-lowering agents.4 Among very high-risk patients, the percentage is increased to more than 80 percent.4 It is estimated that less than one percent of people with FH (heterozygous and homozygous forms) in most countries are diagnosed.5
GLAGOV Study Design
GLAGOV (GLobal Assessment of Plaque ReGression with a PCSK9 AntibOdy as Measured by IntraVascular Ultrasound) is a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial designed to evaluate the effect of Repatha on the change in burden of CAD in 968 patients undergoing cardiac catheterization and on optimized background statin therapy. Patients were randomized 1:1 into two treatment groups to either receive monthly Repatha 420 mg or placebo subcutaneous injections. The primary endpoint was change in percent atheroma volume (PAV) from baseline to week 78 compared to placebo, as determined by intravascular ultrasound (IVUS). IVUS is a high-resolution imaging tool that allows for the quantification of coronary atheroma in the coronary arteries.
Secondary endpoints included PAV regression (any reduction from baseline); change in total atheroma volume (TAV) from baseline to week 78; and regression (any reduction from baseline) in TAV.
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