FDA to Review New Evolocumab Cardiovascular Outcomes Data
Amgen announced that they have submitted a supplemental Biologics License Application (sBLA) for Repatha (evolocumab) to add cardiovascular outcomes data which shows an additional reduction in heart attacks, strokes, and coronary revascularizations beyond what is possible with optimized statin therapy.
The submission to the Food and Drug Administration (FDA) is based results from the ‘FOURIER' study which included 27,564 patients with high cholesterol and clinically evident atherosclerotic cardiovascular disease. Participants were randomized to either Repatha 140mg SC every two weeks or 420mg SC monthly plus statin therapy or placebo and statin therapy. The primary endpoint was time to cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.
Results showed that the Repatha plus statin group had a statistically significant 20% (P<0.001) reduction in hard major adverse cardiovascular events (MACE) and a 15% reduction (P<0.001) in the risk of extended MACE. Specifically, the treatment group had a reduction in heart attack risk by 27% (P<0.001), stroke by 21% (P=0.01) and coronary revascularization by 22% (P<0.001). These benefits in risk reduction were also shown to grow over time.
“This [study] demonstrates a significant unmet need, as event rates in the real world are typically two to three times higher than those seen in clinical trial settings,” said Sean E. Harper, MD, EVP of Research and Development at Amgen.
No significant differences were noted between the treatment and control group in terms of adverse events, including in those patients who achieved the lowest levels of low-density lipoprotein (LDL) cholesterol.
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It binds to PCSK9 and inhibits circulating PCSK9 from binding to the LDL receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
Repatha is currently indicated 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 low-density lipoprotein cholesterol (LDL-C); and with other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.
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