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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

Lilly Xigris Indication For Low-Risk Sepsis Could Require Large Study

Lilly's Xigris efficacy assessment in low-risk sepsis patients would require a large trial population, FDA's Anti-Infective Drugs Advisory Committee suggested Oct. 16.

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