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)

The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.

Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug;  FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.