Sanofi and Regeneron Announce New Results from Six Phase 3 Trials Showing that Alirocumab Significantly Reduced LDL Cholesterol

21-Nov-2014 - France

Sanofi and Regeneron Pharmaceuticals, Inc. announced new detailed positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced low-density lipoprotein cholesterol (LDL-C, or "bad" cholesterol). Alirocumab is an investigational fully human monoclonal antibody targeting the protein PCSK9 (proprotein convertase subtilisin/kexin type 9) that is being evaluated for its ability to lower LDL-C.

All six trials, ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, met their primary efficacy endpoint of a greater reduction in LDL-C at 24 weeks, versus either active comparator or placebo, which included standard-of-care therapy. Detailed results from these trials were presented as part of a special session on the ODYSSEY program today, and on November 17 during a late-breaker presentation at the American Heart Association (AHA) Scientific Sessions in Chicago, IL. The companies had announced in July that all six studies met their primary efficacy endpoints.

"In these trials patients treated with alirocumab achieved significant and robust LDL-C reductions compared to baseline," said Jennifer Robinson, M.D., M.P.H., Director of the Prevention Intervention Center, Professor, Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa. "New interim results from ODYSSEY LONG TERM provide further support for alirocumab's consistent safety profile, including in more than 500 patients who achieved LDL-C levels lower than 25 mg/dL."

The trials assessed alirocumab in hypercholesterolemic patients who were at high cardiovascular (CV) risk, had an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH), and/or a history of intolerance to two or more statins, including one at the lowest dose. All patients received alirocumab in addition to standard-of-care lipid-lowering therapy, with the exception of some patients in ODYSSEY ALTERNATIVE.

Original publication

Bruckert E, Hayem G, Dejager S, et al.; "Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients -the PRIMO study."; Cardiovasc Drugs Ther. 2005;19:403-414.

Cohen JD, Brinton EA, Ito MK, Jacobson TA.; "Understanding statin use in America and gaps in patient education (USAGE): an internet-based survey of 10,138 current and former statin users."; J Clin Lipidol. 2012 ;6(3):208-15.

https://www.bionity.com/en/news/150602/sanofi-and-regeneron-announce-new-results-from-six-phase-3-trials-showing-that-alirocumab-significantly-reduced-ldl-cholesterol.html

Original publication

Bruckert E, Hayem G, Dejager S, et al.; "Mild to moderate muscular symptoms with high-dosage statin therapy in hyperlipidemic patients -the PRIMO study."; Cardiovasc Drugs Ther. 2005;19:403-414.

Topics

phase III studies alirocumab cholesterol heterozygous familial hypercholesterolemia

Show all

Organizations

Sanofi-Aventis Regeneron Pharmaceuticals