Four Phase III trials of SAR 236553 meet endpoints for Hypercholesterolemia-Sanofi/Regeneron

Sanofi and Regeneron Pharmaceuticals announced detailed positive results from four Phase III ODYSSEY trials of SAR 236553 (alirocumab) in people with Hypercholesterolemia, all of which met their primary efficacy endpoint. On the primary efficacy endpoint of the ODYSSEY LONG TERM trial, at 52 weeks, there was a 57 percent reduction from baseline in LDL-C levels in the alirocumab group as compared to a 4 percent increase in the placebo group (61 percent reduction in alirocumab group compared to placebo). On the primary endpoint of the ODYSSEY COMBO II trial, at 52 weeks, there was a 50 percent reduction from baseline in LDL-C levels in the alirocumab group compared to an 18 percent reduction in the ezetimibe group (32 percent reduction in alirocumab group compared to ezetimibe group).

In the ODYSSEY FH I and FH II trials, at 52 weeks, in FH I, there was a 47 percent reduction from baseline and in FH II, a 50 percent reduction from baseline in LDL-C levels in the alirocumab groups compared to an increase of 9 and 8 percent in the placebo groups, respectively (56 and 58 percent reduction compared to placebo). Sanofi and Regeneron anticipate alirocumab regulatory submissions in the US and EU by the end of 2014. Data was presented at ESC Congress 2014.