Eli Lilly Announce Withdrawal of Xigris®
On 25 October 2011 Eli Lilly and Company announced withdrawal of 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.
The company is working with regulatory agencies on this withdrawal, and is in the process of notifying healthcare professionals and clinical trial investigators.
Patients currently receiving treatment with Xigris should have treatment discontinued, and new patients should not be started on Xigris treatment.
More information for clinicians about the withdrawal of activated drotrecogin alfa is available on the European Medicines Agency and the U.S. Food and Drug Administration websites. A link to the Eli Lilly Press release is here.





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