Alirocumab: Additional Phase III data

Additional data from the double-blind, international Phase III ODYSSEY MONO trial in 103 patients with primary hypercholesterolemia and moderate cardiovascular risk showed that subcutaneous 75 mg alirocumab every 2 weeks for 12 weeks reduced mean LDL-C by 48.1% from baseline vs. 19.6% for 10 mg ezetimibe. Patients received alirocumab at an initial dose of 75 mg, which was increased to 150 mg at week 12 in 14 patients whose LDL-C was >70 mg/dL at week 8. Data were presented at the American College of Cardiology meeting in Washington, D.C. Sanofi and Regeneron previously reported that alirocumab met the primary endpoint of reducing mean LDL-C from baseline to week 24 vs. ezetimibe (47.2% vs. 15.6%, p<0.0001) (see BioCentury, Oct. 21, 2013). ...