Positive results from ODYSSEY LONG TERM trial for Praluent (alirocumab) for hypercholesterolemia- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. announced that 18-month (78-week) results of a Phase III trial of Praluent (alirocumab), an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol (LDL-C or "bad" cholesterol) by an additional 62 percent at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks.

The alirocumab group, as compared with the placebo group, had higher rates of injection-site reactions (5.9% vs. 4.2%), myalgia (5.4% vs. 2.9%), neurocognitive events (1.2% vs. 0.5%), and ophthalmologic events (2.9% vs. 1.9%). In a post-hoc analysis, the rate of major adverse cardiovascular events (death from coronary heart disease, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization) was lower with alirocumab than with placebo (1.7% vs. 3.3%; hazard ratio, 0.52; 95% confidence interval, 0.31 to 0.90; nominal P=0.02).

See-"Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events"- Jennifer G. Robinson, M.D., M.P.H., et.al., and the ODYSSEY LONG TERM Investigators, 15 March 2015, DOI: 10.1056/NEJMoa1501031.