Amgen Studies Show Amgen's Novel Investigational Cholesterol-Lowering Medicine Evolocumab Significantly Reduced LDL Cholesterol By 55-66% Compared To Placebo
- Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.1
- The three Phase 3 studies evaluated evolocumab in different patient populations: as monotherapy in patients with high cholesterol (MENDEL-2); as a long-term 52-week therapy in patients with high cholesterol on risk-based lipid-lowering therapy (DESCARTES); and in combination with statins and other lipid-lowering therapies in patients with heterozygous familial hypercholesterolemia (HeFH), a genetic disorder characterized by elevated LDL-C levels (RUTHERFORD-2).
- In MENDEL-2, the most common adverse events (AEs) (=2 percent in evolocumab combined group) were headache, diarrhea, nausea and urinary tract infection. The most common AEs (>5 percent in evolocumab) in the DESCARTES study were nasopharyngitis, upper respiratory tract infection, influenza and back pain. In RUTHERFORD-2, the most common AEs (=2 percent in the combined evolocumab group) were nasopharyngitis, headache, contusion (i.e., bruise), back pain, nausea, arthralgia, upper respiratory tract infection, influenza, myalgia and pain in extremity.