Takeda Pharmaceutical Receives FDA Fast Track Designation for TAK-

JCNN News Summaries - Japan Corporate News Network, Jul 29, 2005 by Aki Tsukioka

Tokyo, July 29, 2005 - (JCN) - Takeda Pharmaceutical announced on July 27 that one of its US affiliates, Takeda Global Research & Development Center of Illinois, has received fast track designation by the US Food and Drug Administration (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 including cytokine by the signal transduction mediated by Toll-like receptor (TLR4).

Based on the results of clinical trials conducted in the Japan, EU and the US, 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.