Alirocumab: Extension study data

Data from 54 evaluable patients in a 4-year, open-label extension of the 12-week, double-blind, placebo-controlled, international Phase II Study R727-CL-1003 in 77 patients with heFH showed that 150 mg subcutaneous alirocumab every 2 weeks led to a mean reduction in LDL-C of 59.5% at week 64 compared to baseline of the extension (p<0.0001). Additionally, alirocumab led to a 4.1% increase in HDL-C at week 64 compared to baseline of the extension (p<0.05) and reductions of 45% in apolipoprotein B (APOB), 28.6% in lipoprotein(a) (LPA), 38.4% in total cholesterol and 50.5% in non-HDL-C at week 64 compared to baseline of the extension (p<0.0001 for all). Data were presented at the American College of Cardiology meeting in Washington, D.C.

Study R727-CL-1003 enrolled patients with elevated LDL-C (>=100 mg/dL) despite receiving lipid lowering therapy consisting of statins with or without ezetimibe to receive placebo or 100, 150 or 300 mg alirocumab every 4 weeks or 150 mg alirocumab every 2 weeks. Sanofi and Regeneron previously reported that all 4 dose regimens of alirocumab added to lipid lowering therapy met the primary endpoint of reducing mean LDL-C from baseline to week 12 vs. lipid lowering therapy alone (see BioCentury, Nov. 14, 2011 & June 18, 2012). ...