Takeda Cholesterol Drug Filing Set Back Due To Liver Enzyme Data
This article was originally published in PharmAsia News
Executive Summary
A cholesterol drug Takeda had planned to file in the first quarter of 2008 has been delayed after elevated transaminase levels were seen in some patients taking a higher dose of the product in clinical trials, the Japanese firm announced Oct. 29. FDA has requested additional clinical trial data on TAK-475 (lapaquistat), a squalene synthase inhibitor