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Xigris [drotrecogin alfa (activated)]

April 28, 2005

Audience: Pediatricians, intensivists and infectious disease healthcare professionals

Eli Lilly and FDA notified healthcare professionals of the stopping of enrollment in a randomized, double-blind, placebo-controlled trial of Xigris in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis. A planned interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary endpoint of "Composite Time to Complete Organ Failure Resolution" over 14 days.

A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted. Over the infusion period the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.

[April 21, 2005 -

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