US drug major Eli Lilly (NYSE: LLY) revealed yesterday that it is withdrawing its Xigris (drotrecogin alfa [activated]) product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock.
"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, Lilly's senior vice president and chief medical officer, noting that "patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients."
Will take charge of $75-$95 million
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