Amgen announced positive Phase 3 study data evaluating Repatha (evolocumab) in patients who were receiving apheresis to lower low-density lipoprotein cholesterol (LDL-C). 

In the study (n=39), adults with LDL-C 100–190mg/dL despite regular weekly or biweekly apheresis plus statin therapy (if tolerated) were randomized to receive subcutaneous (SC) Repatha every 2 weeks or continue LDL-apheresis every week or 2 weeks (based on their schedule prior to study entry) for the first 6 weeks. The primary endpoint was the efficacy of SC Repatha vs. regular LDL-C apheresis on reducing the need for continued apheresis at the end of the randomized period.

Treatment with Repatha reached its primary endpoint at the end of the randomization period, and it also met its secondary endpoints, which included percent change from baseline to Week 4 in LDL-C, non-high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol:HDL-C ratio.  

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The study found no new safety concerns and the overall incidence of treatment-emergent adverse events was similar among both groups. 

Sean E. Harper, MD, executive vice president of Research and Development at Amgen, added, “These positive data suggest patients may have an alternative option to help them manage their cholesterol.”

Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor was approved by the Food and Drug Administration (FDA) as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.

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