Sanofi + Regeneron announce pooled analysis from ODYSSEY trial of HeFH patients treated with Praluent (alirocumab)

Sanofi and Regeneron Pharmaceuticals, Inc. announced that in a new pooled analysis of heterozygous familial hypercholesterolemia (HeFH) patients included in the ODYSSEY clinical trial programme, Praluent (alirocumab) significantly reduced low-density lipoprotein cholesterol (LDL-C). This analysis included 1,257 HeFH patients, the largest group of HeFH patients ever studied in a Phase III programme.

At week 24, when the primary efficacy endpoint was assessed, patients treated with Praluent had an average 56 percent greater reduction in LDL-C compared to placebo (p<0.0001) in both arms. Reductions were observed as early as week 4 and were maintained for the duration of therapy, until week 78. Results of this analysis were presented at the ESC Congress 2015 in London, and the 78 week results from two of the four trials included in the analysis, ODYSSEY FH I and II, were concurrently published online in the European Heart Journal.

See- Kastelein JJP, Farnier M, Hovingh GK, et al. Efficacy and safety of the PCSK9 monoclonal antibody alirocumab vs placebo in 1257 patients with heterozygous familial hypercholesterolaemia: analyses up to 78 weeks from four ODYSSEY trials. Oral presentation at ESC Congress 2015 (#5772): 29 August-2 September 2015.

See- Kastelein JJP, Ginsberg HN, Langslet G, et al. "ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia"-. European Heart Journal 2015: doi:10.1093/eurheartj/ehv370.