The FINANCIAL — Takeda Pharmaceutical Company Limited ("Takeda") announced on July 27 that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for a fixed-dose combination tablet of Actos (generic name: pioglitazone HCI) with sulfonylurea for the treatment of type 2 diabetes.
Actos, which was discovered by Takeda, is in the thiazolidinedione (TZD) class of oral antidiabetic medications and targets insulin resistance, which is a characteristic symptom associated with type 2 diabetes. Sulfonylurea primarily acts on beta cells of the pancreas and increasing the amount of insulin secretion by the pancreas. It is expected that by combining these two medications, which have differing mechanisms of action, patients will be able to avoid missing a dose due to the greater ease of administration, thereby allowing patients with type 2 diabetes to better control their blood glucose levels.
A fixed-dose combination tablet of Actos with sulfonylurea was approved under the brand name of Duetact in the U.S. in July 2006 and was approved under the brand name of Tandemact in the EU in January 2007. “Since there are also 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,” said Nancy Joseph-Ridge, M.D., General Manager, Pharmaceutical Development Division of Takeda.
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