Takeda Cholesterol Drug Filing Set Back Due To Liver Enzyme Data
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.
As a result of the findings, FDA has also recommended suspension of the clinical studies employing higher doses of the drug. The increase in transaminase elevations, including severe cases, was seen in more patients treated with TAK-475 versus control groups in a pooled analysis of Phase II and Phase III studies conducted in the U.S. and Europe.
"This pattern of ALT elevation has not been observed to date with the lower doses of TAK-475 where frequencies are comparable to control groups," Takeda explained.
Future development plans for TAK-475 are under discussion with FDA, Takeda added.
"Takeda will immediately study the future plans for TAK-475 in the U.S., Europe and Japan, and such plans will be announced once fixed through discussion with the relevant regulatory authorities," the firm said.
The regulatory delay follows several other pipeline setbacks for Takeda. In June, the company announced plans to prioritize TAK-475 and other pipeline projects after a decision to terminate development of a fixed-dose combination of its diabetes drug Actos (pioglitazone) with the investigational angiotensin receptor blocker azilsartan, which was in Phase III ("The Pink Sheet" DAILY, June 1, 2007).
In August, Takeda and development partner Merck Serono said a Phase II study of their monoclonal antibody matuzumab failed to meet its primary efficacy endpoint in metastatic colorectal cancer patients ("The Pink Sheet" DAILY, Aug. 29, 2007).
-Jessica Merrill
This article is reprinted from "The Pink Sheet" DAILY – Oct. 30, 2007
Click here to start your 30-day, risk-free trial of "The Pink Sheet" DAILY – Immediate business intelligence from the company and product level up.
© FDC Reports 2007 - All Rights Reserved
