Regeneron and Sanofi Announce Presentation of Detailed Positive Results from Four Pivotal Alirocumab Trials

Regeneron Pharmaceuticals, Inc. and Sanofi has announced detailed positive results from four Phase III ODYSSEY trials of alirocumab in people with hypercholesterolemia. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).  Results from the four ongoing trials, all of which met their primary efficacy endpoint, were presented at a Hot Line session at the ESC Congress 2014 in Barcelona, Spain.

"Across these four trials, alirocumab showed significant and sustained reductions in LDL-C over one year on top of standard-of-care statin therapy across different patient types," said Jennifer Robinson, MD, MPH, Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "We are also encouraged by the consistent safety profile across the trials, including in ODYSSEY LONG TERM, the largest Phase III trial of a PCSK9 inhibitor, with the longest follow-up period reported to date."