The FDA recommended that Takeda halt high-dose clinical studies of its TAK-475 cholesterol drug due to possible liver side effects, asking for additional data on the drug.
News of the setback sent shares of Takeda tumbling 12%, to $61.59 on the Tokyo Stock Exchange.
Financial firm Mitsubishi UFJ Securities lowered its rating on Takeda from “3” to “2,” predicting that the overseas launch of TAK-475 could be delayed by more than two years.
Takeda had planned to seek approval for the drug this April and hoped TAK-475 could help replace sales of its best-selling diabetes drug, Actos, when that drug's patent expires in 2011. Actos, with global sales of $2.8 billion, accounted for a quarter of Takeda's revenue last year.