American pharma company Isis Pharmaceuticals (Nasdaq: ISIS) has announced that its Phase III study of Kynamro (mipomersen sodium) met its primary endpoint.
The FOCUS FH trial looked at patients with severe heterozygous familial hypercholesterolemia, and met its primary endpoint, a statistically significant reduction in LDL-cholesterol after 60 weeks of treatment of once-weekly injections of 200mg Kynamro compared to placebo.
LDL-cholesterol reduction was similar to that observed in previous Phase III 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 III studies. Genzyme, a Sanofi company (Euronext: SAN), which is commercializing the product, will provide a more in depth review of the safety and efficacy data.
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