FDA: Xigris Pulled From Global Market
Drug failed to show survival benefit in severe sepsis
TUESDAY, Oct. 25 (HealthDay News) -- Xigris (drotrecogin alfa [activated]), used in the treatment of patients with severe sepsis, is being voluntarily pulled from the market by its manufacturer, Eli Lilly and Company, after failing to show a survival benefit in these patients, according to a drug safety notification issued Oct. 25 by the U.S. Food and Drug Administration.
To evaluate the mortality rate associated with the administration of Xigris, researchers enrolled 1,696 patients in a clinical trial in which 851 patients received Xigris and 845 received a placebo.
At 28 days, the researchers saw little difference between the two groups; the all-cause mortality rate in the treatment group was 26.4 percent, compared with 24.2 percent in the placebo arm.
According to the FDA, "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."