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July 27, 2009

Takeda Submits NDA for Actos Combo in Japan

Takeda has announced filing for a New Drug Application (NDA) in Japan for a fixed-dose combination tablet of Actos with sulfonylurea for the treatment of type 2 diabetes. Actos, which was discovered by Takeda, is a thiazolidinedione class of oral antidiabetic medications that targets insu

By cms admin

Takeda has announced filing for a New Drug Application (NDA) in Japan for a fixed-dose combination tablet of Actos with sulfonylurea for the treatment of type 2 diabetes.

Actos, which was discovered by Takeda, is a thiazolidinedione class of oral antidiabetic medications that targets insulin resistance, a characteristic symptom associated with type 2 diabetes.

Sulfonylurea primarily acts on beta cells of the pancreas to increase the amount of insulin secretion.

By combining these two medications, Takeda hopes to improve drug administration, allowing patients with type 2 diabetes to better control their blood glucose levels.

Pharmaceutical Development Division of Takeda general manager Nancy Joseph-Ridge said that there are many cases where Actos and sulfonylurea are administered in combination in Japan.

“We are expecting that a fixed-dose combination tablet of Actos with sulfonylurea, if approved, will positively contribute to the treatment of Japanese patients with diabetes as well,” Joseph-Ridge aid.

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A fixed-dose combination tablet of Actos with sulfonylurea was approved under the brand name of Duetact™ in the US in July 2006. The medication was also approved under the brand name of Tandemact™ in the EU in January 2007.

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