Washington, DCThe US Food and Drug Administration (FDA) has issued a communication 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)]. Eli Lilly took the decision based on results from a recently completed clinical trial in which Xigris failed to show a survival benefit in patients with severe sepsis and septic shock. Xigris is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.
According to the FDA statement, "Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris."
The recently completed PROWESS-SHOCK trial enrolled 1696 patients, 851 patients in the Xigris arm and 845 patients in the placebo arm. Results based on preliminary analyses done by Eli Lilly, that were submitted to the FDA, showed no statistically significant difference between the two arms.