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Takeda Pharmaceutical Company Limited announced today that it filed a New Drug Application to the Ministry of Health, Labour and Welfare for a fixed dose combination tablet of Actos(R) (generic name: pioglitazone HCI) with metformin for the treatment of type 2 diabetes
Osaka, Japan | October 30, 2008 | Takeda Pharmaceutical Company Limited ("Takeda") announced today 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 metformin 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. 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.
“The fixed dose combination tablet of Actos with metformin, if approved, will be the first fixed-dose combination treatment for type 2 diabetes in Japan,” said Masaomi Miyamoto, Ph.D., General Manager of Pharmaceutical Development Division of Takeda. “By building on the September NDA submission of Actos® orally disintegrating tablets in Japan, and by providing this fixed dose combination tablet as a new treatment option, we are striving to meet the needs of a greater number of patients with diabetes.”
A fixed dose combination tablet of Actos with metformin was approved under the brand name of Actoplus met® in the U.S. in August 2008 and was approved under the brand name of Competact® in the E.U. in July 2007.
SOURCE: Takeda Pharmaceutical Company Limited |
