Eisai Sepsis Drug Fails in Phase III Trial
Eisai has suffered a setback that its severe sepsis treatment eritoran has failed in a late-stage trial.
Eisai has reported that eritoran, its experimental treatment for severe sepsis, has failed to meet the primary endpoint of a Phase III trial.
The company has decided not to submit marketing authorisation applications to regulatory authorities in the US, EU and Japan by the end of the fiscal year as previously planned.
Severe sepsis causes approximately 215,000 deaths in the US every year, with a mortality rate of approximately 30%. It is estimated to affects 18 million people worldwide every year.
The global, randomised, double-blind, placebo-controlled trial evaluated a population that had a moderate-to-high risk of mortality as determined by baseline APACHE II scores from (21 to 37).
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