1-Year results from OSLER trial of anti-PCSK9 monoclonal antibody evolocumab

Evaluation of Evolocumab (AMG 145), a Fully Human Anti‐PCSK9 IgG2 Monoclonal Antibody, in Subjects With Hepatic Impairment

Evolocumab binds PCSK9, increasing low-density lipoprotein cholesterol (LDL-C) receptors and lowering LDL-C. Target-mediated evolocumab elimination is attributable to PCSK9 binding. As circulating PCSK9 and LDL-C levels are primarily regulated by the liver, we compared evolocumab pharmacokinetics, pharmacodynamics, and safety in individuals with and without hepatic impairment. An open-label, pa...

Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial.

BACKGROUND Evolocumab (AMG 145), a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein cholesterol (LDL-C) in phase 2 studies of 12 weeks' duration. The longer-term efficacy and safety of PCSK9 inhibition remain undefined. METHODS AND RESULTS Of 1359 randomized and dosed patients in the 4 evolocumab phase 2 parent st...

One-Year Efficacy and Safety of Evolocumab in Japanese Patients　- A Pooled Analysis From the Open-Label Extension OSLER Studies.

BACKGROUND Evolocumab, a fully human monoclonal antibody against PCSK9, significantly reduced low-density lipoprotein-cholesterol (LDL-C) levels in Japanese patients by up to 76% when administered with a statin. We evaluated the efficacy and safety of 1 year of evolocumab in a pooled analysis of patients from the 12-week YUKAWA studies who continued into the open-label extension (OLE) OSLER stu...

Evolocumab to reduce cardiovascular events: results of the (FOURIER) multinational trial

Proprotein convertase subtilisin-kexin type 9 (PCSK9) is a protease that binds to the extracellular compartment of the LDL receptor, hence, targeting the LDL receptor to the lysosomal compartment of the cell for degradation [1]. Consequently, PCSK9 prevents recycling of the LDL receptor to the cell surface, thereby modifying LDL clearance. With the discovery of PCSK9 protein as a potential ther...

Development of a Novel Inhibitory Chimeric Anti-HER2 Monoclonal Antibody