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Home Industry News Takeda provides development status update

Takeda provides development status update

1st November 2007

Takeda has announced an update to the development status of its investigational compound TAK-475 (lapaquistat acetate).

Tak-475 has been indicated for the treatment of hypercholesterolemia in the US, Japan and Europe.

The US Food and Drug Administration (FDA) has requested additional clinical data prior to the submission of a New Drug Application (NDA) for TAK-475 following talks with Takeda.

In addition, recommendations have been made to suspend clinical studies that involve higher doses.

This request comes off the back of an observed increased frequency of transaminase elevations with the higher dose of TAK-475, including severe cases compared to that seen in control groups in a pooled analysis of Phase II and III studies completed in the US and Europe.

Takeda has confirmed that the FDA’s requests have delayed plans for US NDA submission, with a target date of the first quarter of fiscal 2008 being dropped by the company.

The Japanese pharmaceutical firm will continue to discuss future plans with the FDA and development plans in Europe and Japan will also be subject to the considerations expressed by the administration.

Earlier this month, Takeda and Affymax were recognised with the 2007 Deal of Distinction award for their global development and marketing agreement for Hematide as a treatment for anaemia.

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