Amgen Announces Positive Top-Line Results From Phase 3 GLAGOV Imaging Study Of Repatha® (Evolocumab)
THOUSAND OAKS, Calif., Amgen
today 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. 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. 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. Among very high-risk
patients, the percentage is increased to more than 80 percent. It is estimated that less
than one percent of people with FH (heterozygous and homozygous forms) in most
countries are diagnosed.
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