Darapladib: Phase III data
Top-line data from the double-blind, international Phase III SOLID-TIMI 52 trial in >13,000 patients who began treatment within 30 days following an ACS showed that once-daily 160 mg oral darapladib plus standard of care (SOC) missed the primary endpoint of improving time to the first occurrence of any component of the composite of CHD death, MI and urgent coronary revascularization for myocardial ischemia vs. placebo plus SOC. GlaxoSmithKline said there were no major safety concerns for darapladib. SOC could include a statin, aspirin and blood pressure medications. The pharma said further analysis of SOLID-TIMI 52 is ongoing, but that the outcome of the trial does not support a regulatory submission for darapladib in atherosclerosis, nor does GSK plan to start any new trials with darapladib in the indication. ...