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FDA- Lilly & Co. Pulls Xigris from Market

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susan_harr6 years ago

“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,” FDA.

Drotrecogin alfa (Xigris) was approved by the FDA in 2001 and is indicated for “the reduction of mortality in adult patients with severe sepsis who have a high risk of death.” In a Drug Safety Communication released today (October 25, 2011) the FDA announced that the manufacturer of Xigris, Eli Lilly, is withdrawing the drug from markets worldwide and recommends that the following actions be taken:

  • 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.


The market withdrawal announcement came after the PROWESS-SHOCK trial study failed to show that the drug helped patients live longer. “While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use,” Lilly's chief medical officer said in a press release. 

  • The trial was ordered by European regulators as a condition to allow for the continued marketing of Xigris in Europe.
  • The study included 1696 patients- 851 patients were given Xigris and 845 patients were given a placebo.
  • The study was stopped early when it became apparent that the drug showed no significant survival benefit.
  • “We believe the original Xigris approval [in 2001] was appropriate and these recent results were quite unexpected,” a representative from Lilly stated.

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