FDA deals Takeda pipeline setback

Share this article:

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.

Share this article:

Email Newsletters

More in News

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union