BLA for Novel Cholesterol Drug Submitted to FDA
Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol. Evolocumab is an investigational fully human monoclonal antibody that inhibits protein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood.
The BLA includes data from 6,800 patients, including over 4,500 patients with high cholesterol in 10 Phase 3 trials, evaluating the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies, patients who cannot tolerate statins, patients with heterozygous familial hypercholesterolemia (HeFH), and patients with homozygous familial hypercholesterolemia (HoFH).
Amgen has also announced positive top-line results from the Phase 3 YUKAWA-2 (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study evaluating evolocumab in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol. The study met its co-primary endpoints of the percent reduction from baseline in LDL-C at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The percent reduction in LDL-C was clinically meaningful, statistically significant, and consistent with the results observed for the same doses in the Phase 2 YUKAWA trial of evolocumab vs. placebo.
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