Phase III trials of Praluent for Hypercholesterolemia meet endpoints-Regeneron/Sanofi

Regeneron Pharmaceuticals and Sanofi have announced that two new ODYSSEY Phase III trials assessing Praluent (alirocumab) administered every four weeks, have met their primary efficacy endpoints in patients with Hypercholesterolemia. The trials compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C, or "bad" cholesterol) at 24 weeks with alirocumab versus placebo. ODYSSEY CHOICE I evaluated the efficacy and safety of alirocumab in 803 patients with hypercholesterolemia at moderate to high cardiovascular (CV) risk. It compared alirocumab 300 mg every four weeks with placebo. More than two-thirds (68 percent) of patients also received statin therapy. ODYSSEY CHOICE II evaluated the efficacy and safety of alirocumab in 233 patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. No patients took statins.

The most common adverse events in the trials (occurring in at least 5 percent of alirocumab-treated patients) were injection site reactions, headache, upper respiratory tract infection, arthralgia, nausea, sinusitis, pain in extremity, and fatigue. In both trials, alirocumab-treated patients who did not achieve their pre-specified LDL-C goals, or who did not achieve at least a 30 percent reduction in their LDL-C levels from baseline, were switched to receive alirocumab 150 mg every two weeks at 12 weeks.Detailed data will be presented at future medical congresses.

Comment: Amgen has filed competitor, evolocumab last year, and that drug could access the market between 6 months and one year before Regeneron and Sanofi's alirocumab. Sanofi and Regeneron are pursuing a 12-study effort of their own with plans for an FDA application in 2015.