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FDA Xigris Efficacy Analysis Suggests APACHE II Test Can Guide Therapy

Executive Summary

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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APACHE II Sepsis Score Best Indicator Of Xigris Benefit, Labeling States

The APACHE II sepsis score is the most appropriate tool to estimate the likelihood of a Xigris benefit in a particular patient, labeling for Lilly's biologic states

APACHE II Sepsis Score Best Indicator Of Xigris Benefit, Labeling States

The APACHE II sepsis score is the most appropriate tool to estimate the likelihood of a Xigris benefit in a particular patient, labeling for Lilly's biologic states

Xigris Best-Case Label Would Be 400,000 Patients; User Fee Date Is Oct. 27

Lilly is hoping to receive Xigris labeling permitting use in approximately 400,000 severe sepsis patients per year.

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