One of Takeda's brightest drug prospects has run into a major stumbling block. The FDA is recommending the company halt clinical trials that are using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. The agency is also looking for additional clinical data ahead of an NDA for the therapy, which is in late-stage studies.
Analysts quickly estimated that the hitch will add at least two years to the development timeline of the drug, which had been tapped as a possible blockbuster able to make up for lost Actos revenue when the diabetes drug loses patent protection in 2011. With the FDA on high alert regarding any safety issues, the potential for liver damage could also be a deal killer for Takeda, which had been expected to file for approval as early as next April. TAK-475 is a "squalene synthase inhibitor" which is being studied to lower levels of bad cholesterol. If it is successful, it would be the first such drug on the market.
- see Takeda's release on the drug
- here's the AFX report for more information