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news.Eisai's severe sepsis treatment eritoran (generic name; E5564) has failed to meet primary endpoint in a randomized, double-blind, placebo-controlled Phase III ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial.
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The Phase III trial enrolled severe sepsis patients with a moderate-to-high risk of mortality as determined by baseline APACHE II (Acute Physiology and Chronic Health Evaluation II) scores from 21 to 37.
The purpose of the study was to evaluate the 28 day all-cause mortality risk of eritoran versus placebo.
Following the trial, Eisai has decided not to file marketing authorization applications of eritoran with the regulatory authorities in the US, European Union (EU) and Japan by the end of fiscal year 2010 as previously planned.
Further Eisai said that it will continue its analysis of the eritoran clinical trial data and determine next steps.