ISIS Pharmaceuticals reports positive data from its Phase 3 LDL-cholesterol study

ISIS Pharm reports positive data from its Phase 3 study of Kynamro Focus FH , showing the trial met its primary endpoint of reduction in LDL-cholesterol.
Co announced that the FOCUS FH phase 3 study of Kynamro (mipomersen sodium) in patients with severe heterozygous familial hypercholesterolemia (severe HeFH) met its primary efficacy endpoint, a statistically significant reduction in LDL-cholesterol after 60 weeks of treatment of once weekly injections of 200 mg of Kynamro compared to placebo.

LDL-cholesterol reduction was similar to that observed in previous phase 3 studies. In addition, based on the data available for review, the safety profile of Kynamro observed in the FOCUS FH trial was similar to the safety profile reported in previous phase 3 studies.