Takeda submits FDA application for once-a-day diabetes pill

OSAKA, Japan Takeda Pharmaceuticals is seeking approval from the Food and Drug Administration to sell its new drug alogliptin, a diabetes pill that is taken once daily as a treatment for Type 2 diabetes, according to Bloomberg.com.

The company is hoping this drug will help its sales after its other diabetes medication Actos loses patent protection in 2011. “Takeda needs a new source of revenue,'' said Kumi Miyauchi, an equities analyst at Daiwa Research Institute, in a telephone interview with Bloomberg. If approved, Takeda may be able to start selling the drug in early 2009, generating as much as $2 billion per year, said Miyauchi.

Takeda's filing was supported by data from six final-stage trials involving more than 2,000 patients conducted in 220 centers worldwide, Takeda said. Results of second and third stages of clinical studies on alogliptin will be published this year, Takeda spokesman Seizo Masuda said. Patients taking the medicine weren't inclined to gain weight, a potential side effect with Actos, he said.

Also, Takeda and Abbott Laboratories have filed for FDA approval for their drug TAK-390MR, proton pump inhibitor that will treat diseases caused by stomach acid.