Lilly announced that it is withdrawing Xigris (drotrecogin alfa [activated] injection) from all markets following results of the PROWESS-SHOCK study, which showed that the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris should not be initiated for new patients.

Xigris, a recombinant form of human Activated Protein C, was approved by the FDA in November 2001 for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (e.g., as determined by APACHE II) based on data from the PROWESS study.

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