Phase 3 study of eritoran for the treatment of severe sepsis
Eisai announced it will not be asking for marketing authorization for eritoran from the FDA based on results from its Phase 3 study for the treatment of severe sepsis. This study, known as the ACCESS trial, was a global, randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of eritoran as a potential treatment for severe sepsis. The study did not meet its primary endpoint of reduction in 28-day all-cause mortality in patients with severe sepsis.
Eritoran is believed to block activation of toll-like receptor 4 (TLR4). TLR4 may play an important role in the course of severe sepsis.
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