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Xigris Serious Bleeds Can Be Minimized If Invasive Procedures Avoided - Lilly

Executive Summary

Serious bleeding events as a result of Xigris administration can be reduced by avoiding invasive procedures during the drug infusion period, Lilly indicates in advisory committee briefing documents for the sepsis agent.

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FDA's Anti-Infective Drugs Advisory Committee will consider Lilly's Xigris (drotrecogin alfa) BLA on Oct. 16 at the Hilton in Gaithersburg, Md. starting at 8:30 a.m. The original Sept. 12 meeting was rescheduled following the terrorist attacks on Washington, D.C. and New York City (1"The Pink Sheet" Sept. 17, pp. 10 & 212)

Xigris meeting rescheduled

FDA's Anti-Infective Drugs Advisory Committee will consider Lilly's Xigris (drotrecogin alfa) BLA on Oct. 16 at the Hilton in Gaithersburg, Md. starting at 8:30 a.m. The original Sept. 12 meeting was rescheduled following the terrorist attacks on Washington, D.C. and New York City (1"The Pink Sheet" Sept. 17, pp. 10 & 212)

FDA Xigris Efficacy Analysis Suggests APACHE II Test Can Guide Therapy

An FDA analysis of Lilly's Xigris Phase III efficacy data suggests that the APACHE II sepsis scale may be a useful guide for identifying candidates for therapy.

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