FDA calls for Takeda to stop high-dose cholesterol drug trials

WASHINGTON The Food and Drug Administration has recommended that Takeda Pharmaceuticals stop conducting its high-dose trials of TAK-475, a cholesterol drug, due to concerns over possible liver damage.

The drug had been revealed to increase transaminase elevations, which is a warning signal of possible liver damage, in high and also in comparable low-level doses. This has made the FDA also request additional clinical data before the company submits an application for the drug.

The additional clinical studies will set back Takeda’s plans to submit an application for TAK-475 by the end of June 2008, the company said, adding it is discussing future development plans with the FDA and European and Japanese regulatory authorities.