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June 30, 2005
OSAKA, JAPAN --- Takeda Pharmaceutical Company Limited ("Takeda") announced today that its wholly owned subsidiary, Takeda harmaceuticals North America, Inc. ("TPNA”) submitted through Takeda Global Research & Development Center Inc., a new drug application (NDA) for a new oral medication that combines pioglitazone HCL and glimepiride, a sulfonylurea, to the U.S. Food and Drug Administration(FDA), for treatment of type 2 diabetes.
Takeda is the originator of thiazolidinedione derivatives and Actos® is a member of the thiazolidinedione class of "insulin-sensitizing" agents, and it directly targets insulin resistance. Glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels. The company is seeking approval to bring the medication to market in the United States.
TPNA launched Actos® in August 1999, jointly with Eli Lilly and Company ("Lilly") as a co-promotion partner, for the treatment of type 2 diabetes as monotherapy and in combination with sulfonylureas, insulin or metformin.
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