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 world wide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)].
Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris.
All remaining Xigris should be returned to the supplier from whom it was purchased.
In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to meet the primary endpoint of a statistically significant reduction in 28-day all cause mortality in patients treated with Xigris compared with placebo. The study also fails its secondary endpoint of a reduction of mortality in the population of patients with severe protein C deficiency.
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).
These questions call into question the overall benefit-risk balance of Xigris for the indicated patient population (severe sepsis). Eli Lilly has thus decided to withdraw the prduct from the market worldwide.
Xigris - RIP
Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris.
All remaining Xigris should be returned to the supplier from whom it was purchased.
In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to meet the primary endpoint of a statistically significant reduction in 28-day all cause mortality in patients treated with Xigris compared with placebo. The study also fails its secondary endpoint of a reduction of mortality in the population of patients with severe protein C deficiency.
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).
These questions call into question the overall benefit-risk balance of Xigris for the indicated patient population (severe sepsis). Eli Lilly has thus decided to withdraw the prduct from the market worldwide.
Xigris - RIP
