Xigris drotrecogin alfa: Additional Phase III data

Additional data from the double-blind, international Phase III PROWESS-SHOCK trial in 1,697 patients showed that Xigris led to a 90-day mortality rate of 34.1% vs. 32.7% for placebo (p=0.56). In a subgroup of patients with severe protein C deficiency, Xigris led to a 28-day mortality rate, a secondary endpoint, of 28.7% vs. 30.8% for placebo (p=0.54). Data were published in the New England Journal of Medicine. Last year, Eli Lilly withdrew Xigris from the global market after data from the trial showed the drug missed the primary endpoint of reducing the 28-day all-cause mortality rate vs. placebo (26.4% vs. 24.2%, p=0.31) (see BioCentury, Oct. 31, 2011). ...