Amgen has 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.

For the full press release, please go here.