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27 Aug 2017

Regeneron and Sanofi to present new analyses from Praluent injection trials

Presentations include results from ODYSSEY APPRISE, an open-label study in 16 European countries and Canada in patients with severe hypercholesterolemia at high cardiovascular risk.

Regeneron Pharmaceuticals and Sanofi have announced new analyses from Praluent (alirocumab) Injection clinical trials will be presented at the European Society of Cardiology (ESC) Congress 2017, 26-30 August in Barcelona, Spain.

This year's presentations include results from ODYSSEY APPRISE, an open-label study in 16 European countries and Canada in patients with severe hypercholesterolemia at high cardiovascular risk, as well as new post hoc analyses from the ODYSSEY clinical trial program. Additionally, an analysis of the risk of atherosclerotic cardiovascular disease events in a real-world population of patients with diabetes treated with statins will also be presented.

Praluent is a human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), which is approved in more than 50 countries worldwide, including the US, Japan, Canada, Switzerland, Mexico, Brazil and the European Union (EU). The effect of Praluent on cardiovascular (CV) morbidity and mortality has not been determined.

Presentations at the ESC Congress 2017 include

1) Oral Presentation:

  • Risk of incident atherosclerotic cardiovascular disease events by atherogenic lipid levels in a real-world population of 62,428 on-statin individuals with diabetes (Rana).
  • 2) Poster Presentations:

  • Open-label ODYSSEY APPRISE study: interim data from the first 843 patients (Cariou)
  • Assessment of absolute reductions in LDL-C and other lipid parameters associated with alirocumab therapy: results from across the Phase III ODYSSEY program (Roth)
  • Predictive factors for alirocumab dose increase in patients with hypercholesterolemia and high cardiovascular risk: from the ODYSSEY COMBO I and II trials (Vallejo-Vaz).
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