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Association of Xigris with Intracranial Hemorrhage in Pediatric Patients and Discontinuation of Study

F1K-MC-EVBP (Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis) based on failure to reach desired clinical endpoints and an unfavourable benefit/risk profile

May 6, 2005 | Health Canada

Eli Lilly Canada Inc., following discussions with Health Canada, would like to inform you of important safety information regarding Xigris [drotrecogin alfa (activated), recombinant human activated Protein C, rhAPC]. Xigris is indicated for the treatment of adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g. as determined by APACHE II score or multiple organ dysfunctions).

Eli Lilly and Company recently stopped enrollment in study EVBP, based on a recommendation from the Data Monitoring Committee. Interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary outcome of Complete Organ Failure Resolution over 14 days.

There was a numerical increase in the rate of intracranial hemorrhage (ICH) in the Xigris versus the placebo group, primarily seen in patients aged 60 days or less.

Xigris is not indicated for use in pediatric severe sepsis (patients < 18 years old).

Based on the recommendation of the Data Monitoring Committee (DMC), Eli Lilly and Company recently stopped enrollment in study EVBP, a randomized, double-blind, placebo-controlled trial of Xigris [drotrecogin alfa (activated)] in pediatric patients with severe sepsis. Xigris is not indicated for use in pediatric severe sepsis.

The DMC also noted a numerical increase in the rate of intracranial hemorrhage (ICH) in the Xigris versus the placebo group. Over the infusion period (study days 0-6) the number of patients experiencing an 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 (median age of patients enrolled was 2.3 years). Mortality, the rate of serious adverse events, overall serious bleeding events, and major amputations appeared to be similar in the Xigris and placebo groups.

Data collection in study EVBP is ongoing. All patients enrolled will be followed for the complete 28-day study period. Full results of the complete dataset will be available in the latter half of 2005 and publicly presented as soon as possible.


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