Regeneron has investigational product candidates progressing through all stages of human clinical trials.
Alirocumab is a fully human monoclonal antibody that binds a protein called PCSK9. Alirocumab is being evaluated to manage LDL cholesterol, including in people who do not get to their target LDL levels using statin medicines alone. We are developing alirocumab as part of our global antibody in collaboration with Sanofi.
The gene that expresses the PCSK9 protein was discovered in 2003, and a 2006 paper described a genetic link between PCSK9 and LDL cholesterol. In that study, sub normal levels of PCSK9 production due to mutations in the PCSK9 gene were associated with a 28 percent reduction in mean LDL cholesterol and an 88 percent reduction in the risk of a cardiac event in African-Americans and with a 15 percent reduction in LDL cholesterol and a 47 percent reduction in the risk of a cardiac event in white Americans1. These data suggest a strong association between PCSK9, LDL cholesterol, and cardiac risk and open the possibility that a pharmaceutical agent that inhibits PCSK9 may offer clinical utility. This discovery is the basis for the development program with alirocumab.
1Cohen, et al. March 23, 2006. The New Eng Journal of Medicine. 354:1264-1272.
This section discusses pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the indications described in this section.