Jan 012012

A newer post is available reviewing the final published findings for PROWESS-SHOCK in NEJM.

PROWESS-SHOCK results are in, and they sounded the death knell for drotecogin alfa (activated protein C / Xigris), Eli Lilly's often-challenged blockbuster drug for septic shock.

Investigators reported a 28-day all-cause mortality rate of 26.4% in patients treated with activated drotrecogin alfa compared with 24.2% in the placebo group of the study. Citing the lack of benefit, the European FDA (the European Medicines Agency) strongly suggested that Eli withdraw the controversial drug from the European market, which they did "voluntarily."

The FDA advised U.S. physicians and the public of the sudden shakeup with the following statement (excerpt):

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

That's all for Xigris folks!

Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy (European Medicines Agency)

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

Xigris web page as of 10/27/11:

A newer post is available reviewing the final published findings for PROWESS-SHOCK in NEJM.

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Xigris X’d! PROWESS-SHOCK negative; activated protein C yanked from global market