FDAnews
www.fdanews.com/articles/74887-sepsis-drug-granted-fast-track-status

SEPSIS DRUG GRANTED FAST-TRACK STATUS

August 1, 2005

Takeda Pharmaceutical announced that one of its U.S. affiliates, Takeda Global Research and Development Center of Illinois, has received fast-track designation by the FDA for TAK-242, its investigational compound designed for the treatment of severe sepsis.

TAK-242 is a compound that suppresses the production of inflammatory mediators. Based on the results of clinical trials conducted in the Japan, European Union. and the U.S., the company plans to launch a global Phase III clinical trial in August, with consent from both FDA and the Pharmaceuticals and Medical Devices Agency.