Lilly Shuts Down Xigris Trial in Pediatric Patients With Sepsis

Eli Lilly has closed down a clinical trial of Xigris in pediatric patients with severe sepsis after an interim analysis failed to show efficacy for the drug over placebo, Lilly and the FDA recently announced.

Four children with severe sepsis participating in the trial developed intracranial hemorrhages while being treated with Xigris (dro trecogin alfa), compared with one in the placebo group, the FDA said in a MedWatch alert.

Xigris is used to treat adults at a high risk of dying from severe sepsis, a dangerous reaction to bacteria in the bloodstream. The drug is not currently indicated for use in pediatric patients with severe sepsis.

To view the MedWatch alert, go to http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Xigris2 (http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Xigris2).