Xigris X'd! PROWESS-SHOCK negative; activated protein C yanked from global market
www.pulmccm.org
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 X'd! PROWESS-SHOCK negative; activated protein C yanked from global market
Xigris X'd! PROWESS-SHOCK negative; activated…
Xigris X'd! PROWESS-SHOCK negative; activated protein C yanked from global market
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):