Eisai Ph III study for eritoran fails to meet primary endpoint, but perampanel filing due this quarter

There was mixed news for Japanese drug major Eisai (TYO: 4523) yesterday, as the firm reported disappointing late-stage clinical results for its investigational sepsis drug, but also announced that it is now ready to file for approval of an epilepsy drug candidate.

Based on the preliminary findings from the ACCESS (A Controlled Comparison of Eritoran and Placebo in Patients with Severe Sepsis) trial, Eisai said that it will not submit marketing authorization applications to regulatory authorities in the USA, the European Union and Japan by the end of the fiscal year (March 31, 2011), as previously planned. The decision was based on the fact that the study did not meet its primary endpoint of reduction in 28-day all-cause mortality in patients with severe sepsis.

Eisai will continue an analysis of the data and determine next steps and says it remains committed to addressing critical areas of unmet need, such as sepsis, having previously said it expected eritoran to generate peak sales of over $1 billion a year.