FDA Recommends Halt to High-Dose Trials of Takeda Cholesterol Drug
The FDA has recommended Takeda Pharmaceutical stop high-dose trials of its cholesterol drug TAK-475 due to concerns over possible liver damage.
The agency also has requested additional clinical data before Takeda submits a new drug application (NDA) since pooled analyses of Phase II and III clinical trials of the drug revealed more frequent transaminase elevations, a warning signal of possible liver damage, in patients taking high doses.
Patients on lower doses of TAK-475 (r-INNM: lapaquistat acetate) showed rates of elevated transaminase comparable to those seen in the control groups, the company said.
The additional clinical studies will set back Takeda’s plans to submit an NDA 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.