Eli Lilly announced that it is pulling drotrecogin alfa (Xigris) from all markets after a major clinical trial failed to show a survival benefit among patients taking the drug.
Xigris should be discontinued among patients all patients currently receiving the drug, and clinicians should not prescribe it to any new patients, the company advised
Xigris was first licensed in the U.S. in 2001, but Eli Lilly initiated the PROWESS-SHOCK study in 2008 in order to maintain market authorization in Europe.
Data collection ended in September 2011, and findings from the placebo-controlled clinical trial indicated participants did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality.
“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,” said Timothy Garnett, MD, Lilly’s chief medical officer, in a press release.
“We believe the original Xigris approval [in 2001] was appropriate and these recent results were quite unexpected,” Garnett said. “A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years.”