Sanofi and Regeneron to present Praluent data at ACC.16
The data presented will include an oral presentation of Praluent’s safety on major adverse cardiac events (MACE) during a two-year period. Other presentations will detail the effectiveness and safety of the medicine by age stratification and response to treatment in patients with mutations in five or less familial hypercholesterolemia (FH) genes.
Praluent is a fully-human monoclonal antibody that is designed to target PCSK9 (proprotein convertase subtilisin/kexin type 9). It was approved in the United States as an additive to diet and statin therapy in order to treat adults with heterozygous familial hypercholesterolemia (HeFH) or those with clinical atherosclerotic cardiovascular disease (ASCVD). The patients treated with Praluent are also in need of lowering their LDL cholesterol levels.
Praluent’s effect on cardiovascular (CV) morbidity and mortality is currently unidentified. The ODYSSEY OUTCOMES trial, which is currently ongoing, will research and determine the effect of CV events due to Praluent. The trial will study approximately 18,000 patients over a five-year period.