The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have announced that Eli Lilly has withdrawn marketing of drotrecogin alfa (Xigris). According to the report, in a recently completed clinical trial (PROWESS-SHOCK trial), drotrecogin alfa failed to show a survival benefit for patients with severe sepsis and septic shock.

The results of the PROWESS-SHOCK study have now become available and failed to meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients treated with drotrecogin alfa compared with placebo. The study also fails its secondary endpoint of a reduction of mortality in the population of patients with severe protein C deficiency. The small difference in the 28-day mortality of the overall population (26.4% in the drotrecogin alfa arm versus 24.2% in the placebo arm; n=1680 patients) is not statistically significant.