Omacor: Additional Phase III data

Additional data from a double-blind, Japanese Phase III trial in 611 patients showed that 2 and 4 g/day oral TAK-085 reduced triglycerides from baseline to week 12, the primary endpoint, by 10.9% and 22.7%, respectively, vs. 11.3% for 1.8 g/day eicosapentaenoic acid (EPA) (p<0.0001 for high-dose TAK-085 vs. placebo). On secondary endpoints, there were no significant differences between treatment groups in the percent change from baseline in LDL-C, HDL-C or total cholesterol at week 12. Data were presented at the Japanese Circulation Society meeting in Fukuoka. The partners previously reported that both doses of TAK-085 met the primary endpoint of non-inferiority to EPA in reducing triglycerides from baseline to week 12 (see BioCentury, May 16, 2011). Last September, Takeda submitted an NDA to Japan's Ministry of Health, Labor and Welfare for TAK-085 to treat hyperlipidemia. ...