Takeda submits New Drug Application for extended-release formula of diabetes drug ACTOplus met

By E. Janene Geiss

Philadelphia, April 3 - Takeda Global Research & Development Center announced Sunday that the company has submitted a New Drug Application for an extended-release version of the combination medication ACTOplus met (pioglitazone Hcl and metformin Hcl) to the Food and Drug Administration for the treatment of type 2 diabetes.

This new formulation would allow for once-daily dosing, while ACTOplus met (immediate release) is already available, being marketed by Takeda Pharmaceuticals North America, Inc., according to a company news release.

ACTOplus met is an oral medication that combines Actos (pioglitazone Hcl), which directly targets insulin resistance - a condition in which the body does not efficiently use the insulin it produces - with metformin, which acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels, officials said.

The NDA submission represents another milestone for Takeda, following the FDA approval of insomnia drug Rozerem (ramelteon).

"Not all patients are alike, especially in diabetes, and the addition of this new product would provide patients and their physicians with more options and greater flexibility, while continuing to provide the benefits of treatment with Actos," John Yates, president of Takeda Global Research & Development Center, said in the release.

Extended-release metformin, one of the active ingredients in ACTOplus met XR, was developed by Andrx Corp. Takeda Pharmaceutical Co. Ltd. signed an agreement with Andrx covering extended-release metformin in December 2003, officials said.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America is a wholly owned subsidiary of Takeda Pharmaceutical Co. Ltd., the largest pharmaceutical company in Japan. In the United States, Takeda markets oral diabetes and cholesterol-lowering treatments. Through the Takeda Global Research & Development Center, Inc., the company has a pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions.

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