FDA Drug Safety Communication: Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit

Safety Announcement

[10-25-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recent study, Xigris failed to show a survival benefit for patients with severe sepsis and septic shock. 

Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris. 

All remaining Xigris product should be returned to the supplier from whom it was purchased. 

In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit. In this trial of 1696 patients, 851 patients were enrolled in the Xigris arm and 845 patients were enrolled in the placebo arm. Results based on preliminary analyses done by Eli Lilly and Company, that were submitted to the FDA, showed a 28-day all cause mortality rate of 26.4% (223/846) in Xigris-treated patients compared to 24.2% (202/834) in placebo-treated patients, for a relative risk of 1.09; 95% CI (0.92, 1.28), and P-value = 0.31 (not statistically significant). 

FDA previously issued an early communication about the ongoing safety review of Xigris in February 2009.