Phase 3 Study Results are IN - and the news is GOOD!
Nineteen of 23 patients who completed the 78 week pivotal study entered the extension study and continued lomitapide at their individualized maintenance dose, with 17 (89%) completing 126 weeks of treatment. The primary efficacy endpoint of the extension study was mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 126. Baseline was determined at the beginning of the pivotal study (Week 0) after a six week run-in period during which patients were stabilized on their other lipid-lowering therapies. Patients remained on a stable regimen of lipid-lowering therapies during the 26-week efficacy phase of the pivotal study. Adjustments to concomitant lipid-lowering treatments were allowed after 26 weeks during the safety phase of the pivotal study and in the extension study. Mean LDL-C levels were reduced by 45.5% from baseline at week 126 (356 +/- 127 mg/dL vs. 189 +/- 120 mg/dL; P