Eisai continues with sepsis trial
This article was originally published in Pharmaceutical Approvals Monthly
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)
You may also be interested in...
Eisai expects product launches and increased sales of existing drugs to help it survive the loss of U.S. patent protection for its best-selling Aricept (donepezil) Alzheimer's disease drug later this year
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.