Sanofi and Regeneron To Present Alirocumab Clinical Data

Sanofi and Regeneron Pharmaceuticals, Inc. have announced that data from alirocumab clinical studies will be presented at the American College of Cardiology's (ACC) 63rd Annual Scientific Session in Washington, DC 29–31 March. 

Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) currently in Phase III studies.

"ACC marks the beginning of the presentation of our Phase III ODYSSEY data in 2014, with the first full data results from the Phase III ODYSSEY MONO study," said Jay Edelberg MD, PhD, Head of the PCSK9 Development and Launch Unit, Sanofi Group. "We are presenting new data with our 150 mg 4-week dosing regimen in individuals not receiving statins and long-term data in heterozygous familial hypercholesterolemia patients."  

"Despite the availability of lipid-lowering therapies, millions of people worldwide are unable to satisfactorily control their levels of low-density lipoprotein-cholesterol," said George D. Yancopoulos, MD, PhD, Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "We have designed a robust Phase III ODYSSEY programme that consists of 14 studies in more than 23,500 patients and we look forward to reporting Phase III data from the majority of the ODYSSEY clinical studies later this year."

Sanofi and Regeneron are developing alirocumab as a potential new treatment for patients with moderate and high cardiovascular risk who face challenges in achieving control of their low-density lipoprotein-cholesterol (LDL-C) levels. Sanofi and Regeneron plan to submit applications for global regulatory approval of alirocumab based on the Phase 3 ODYSSEY programme.