Amgen announced positive top-line data from the Phase 3 GAUSS-3 study evaluating Repatha (evolocumab) in statin-intolerant patients with high cholesterol.
GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) is a three-part Phase 3 trial evaluating the safety, tolerability and efficacy of Repatha in patients with high cholesterol who could not tolerate statins due to muscle-related side effects (MRSE). During the active-controlled part of the trial, treatment effect of Repatha was evaluated and compared to ezetimibe for 24 weeks. The co-primary endpoints were mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24.
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Preliminary results showed that GAUSS-3 met its co-primary endpoints of mean percent reductions from baseline in LDL-C. The mean percent reductions vs. ezetimibe were consistent with findings observed from the previous Phase 2 GAUSS-1 and Phase 3 GAUSS-2 trials. Full detailed results from GAUSS-3 will be revealed at a future medical conference and submitted for publication.
Repatha, an injectable human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), is currently approved as an adjunct treatment for heterozygous familial hypercholesterolemia (HeFH), clinical atherosclerotic cardiovascular disease (ASCVD), or homozygous familial hypercholesterolemia (HoFH) requiring additional LDL-C lowering.
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