Marketing Authorisation Granted For Competact(R) (pioglitazone/metformin) For Type 2 Diabetes In Europe

Main Category: Diabetes
Article Date: 07 Aug 2006 - 0:00 PDT

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Takeda Pharmaceutical Company Limited ("Takeda") today announced that on July 31, 2006, Takeda Global Research & Development Centre (Europe), Ltd. ("TGRD Europe") was granted a marketing authori- sation for Competact(R), a fixed combination tablet of ACTOS(R) (pioglitazone HCl) 15mg and metformin HCl 850mg from the European Commission. TGRD Europe submitted that application on February 28, 2005, and received a positive opinion on June 2, 2006 from The Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency ("EMEA").

ACTOS directly targets insulin resistance, a condition where the body does not efficiently use the insulin it produces, and metformin HCl 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 blood glucose levels.

"We are very pleased with this approval of Competact(R), which enables us to provide an additional treatment option for the patients with type 2 diabetes and healthcare providers who treat them." said Dr. Masaomi Miyamoto, General Manager of Pharmaceutical Development Division of Takeda. "This approval represents one of the achievements in our initiatives aimed for maximizing the product value of ACTOS(R) and also enhancing our franchise in the diabetes field in European markets toward the future."

About Competact(R)

Composition:
Each tablet contains 15mg of pioglitazone (as HCl) and 850mg of metformin HCl.
Indications:
Treatement of type 2 diabetes melllitus patients, particulary overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Posology:
The usual dosage of Competact is 30mg/day pioglitazone plus 1700mg/day of meftormin HCl (this dosage is achievable with one tablet of Competact 15mg/850mg, taken twice a day).

http://www.takeda.com

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