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Eisai continues with sepsis trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

An independent data monitoring committee gives Eisai the green light to complete enrollment for its Phase III ACCESS trial of Eritoran (tetrasodium) to treat severe sepsis. As part of a planned interim analysis, the board evaluated the efficacy and safety of the first 1,500 patients in the placebo-controlled trial, and recommended enrollment continue to the 2,000-patient goal after finding no safety concerns. The ACCESS trial targets a population with severe sepsis that has a moderate to high risk of mortality as determined by baseline APACHE II scores from 21 to 37 - APACHE II is a severity of illness scoring system commonly used in sepsis research. Though sepsis has proven to be a difficult development path (Lilly's Xigris is the only approved treatment), the go-ahead is a good sign for Eisai, which is counting on future Eritoran sales to offset the Aricept patent loss (1PharmAsia News, March 5, 2010)

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