Press Releases
June 6, 2006
Takeda Pharmaceutical Company Limited
Osaka, Japan, June 6, 2006 --- Takeda Pharmaceutical Company Limited ("Takeda") today announced that on June 2, 2006, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") received positive opinion from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA"), recommending to grant a marketing authorization for Competact™, a fixed combination tablet of ACTOS® (pioglitazone HCl) 15mg and metformin HCl 850mg. TGRD Europe sub-mitted that application on February 28, 2005.
ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin HCl acts primarily by reduc-ing the amount of glucose produced by the liver. These medications work in comb-ination to help patients with type 2 diabetes manage their blood glucose levels.
According to CHMP, the indication recommended for approval in the marketing authorisation is: "...the treatment of type 2 diabetes mellitus patients, parti-cularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone." and the detailed con-ditions for the use of this product will be available after the marketing authori-sation has been granted by the European Commission.
"We are looking forward to providing an additional treatment option for the healthcare providers and the patients with type 2 diabetes, once the marketing a uthorisation is granted." said Dr. Kiyoshi Kitazawa, member of the board, General Manager of Pharmaceutical Development Division of Takeda. "At the same time, we believe addition of this combined product will further enhance our franchise in the diabetes field in European markets."
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