ESC 2017: Sanofi, Regeneron to Present New Analyses from Praluent Injection Trials

Sanofi and Regeneron Pharmaceuticals, Inc. announced new analyses from Praluent (alirocumab) Injection clinical trials will be presented at the European Society of Cardiology (ESC) Congress 2017, August 26-30 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 U.S., 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)
- Abstract # P3097
- Monday, August 28, 11:00am – 11:09am CEST

2) Poster Presentations:

Open-label ODYSSEY APPRISE study: interim data from the first 843 patients (Cariou)
- Abstract # P1502
- Sunday, August 27, 8:30am – 12:30pm CEST
Assessment of absolute reductions in LDL-C and other lipid parameters associated with alirocumab therapy: results from across the Phase 3 ODYSSEY program (Roth)
- Abstract # P1512
- Sunday, August 27, 8:30am – 12:30pm CEST
Predictive factors for alirocumab dose increase in patients with hypercholesterolemia and high cardiovascular risk: from the ODYSSEY COMBO I and II trials (Vallejo-Vaz)
- Abstract # P6238
- Tuesday, August 29, 2:00pm – 6:00pm CEST

Additional information on ESC Congress 2017 is available on the congress website.

About Praluent
Praluent inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL-C levels in the blood.

Praluent is approved in more than 50 countries worldwide, including the U.S., Japan, Canada, Switzerland, Mexico and Brazil, as well as the European Union (EU). In the U.S., Praluent is approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. In the EU, Praluent is approved for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-C goals with the maximally-tolerated statin or b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. The effect of Praluent on CV morbidity and mortality has not been determined. ODYSSEY OUTCOMES is prospectively evaluating the effect of Praluent on the occurrence of CV events in approximately 18,000 patients who have experienced an acute coronary syndrome.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.