Date: 2016-09-20
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Heart Association (AHA) Scientific Sessions 2016
Company: Amgen (USA - CA)
Product: Repatha® (evolocumab)
Action
mechanism:
- monoclonal antibody/PCSK9 inhibitor. Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver\'s ability to remove LDL-C, or \"bad\" cholesterol, from the blood.Evolocumab, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.
Disease: coronary artery disease
Therapeutic
area: Cardiovascular diseases
Country:
Trial
details:
- 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.
Latest
news:
- • On September 20, 2016, Amgen 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.
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.
Is
general: Yes
