FDA Approves Actoplus Met

ACTOplus met Takeda Pharmaceuticals - Treatment for Type 2 Diabetes

Osaka, Japan, August 30, 2005 --- Takeda Pharmaceutical Company Limited ("TAKEDA") announced today that its U.S. R&D unit, Takeda Global Research & Development Center, Inc. (Lincolnshire, Ill.) has obtained approval by the U.S. Food and Drug Administration for Actoplus Met for the treatment of type 2 diabetes. Takeda Pharmaceuticals North America, Inc. will launch the product in coming October.

Actoplus Met combines Actos (pioglitazone) and metformin, two widely used diabetes medications, in a single tablet. ACTOS directly targets insulin resistance, a condition where the body does not effectively use the insulin it produces, and metformin 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 plasma glucose levels.

To offer physicians greater flexibility in treating their patients' needs, Actoplus Met will be available in two strengths ? 15 mg/500 mg and 15 mg/850 mg both of which are to be given once a day or in divided doses not exceeding the maximum recommended daily doses of pioglitazone 45 mg and metformin 2,550 mg as mentioned in the approved labeling.

"With this approval, we are pleased to contribute further to the treatment of patients with type 2 diabetes according to individual pathology," said Kiyoshi Kitazawa, Ph.D., a member of the board, general manager of pharmaceutical development division of Takeda. "We are striving to maximize the product value of Actos and to enhance diabetic franchise in the U.S. market, as shown by this approval and also by an NDA submission of a fixed combination product of Actos and glimepiride in June this year."

Posted: August 2005

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ACTOplus met (pioglitazone and metformin) FDA Approval History

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