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Takeda seeks US approval for extended release diabetes drug

Takeda has submitted a new drug application to the FDA for an extended-release version of Actoplus met, its combination medication for the treatment of type 2 diabetes.

This new formulation, Actoplus met XR, would allow for once-daily dosing. The immediate release formulation of the drug is already being marketed by Takeda Pharmaceuticals North America.

Actoplus met is an oral medication that combines Actos, 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.

“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,” said Dr John Yates, president of Takeda global R&D.

Extended-release metformin, one of the active ingredients in Actoplus met XR, was developed by Andrx Corporation and licenses by Takeda in December 2003.