GlaxoSmithKline plc announced that the European Agency for the Evaluation of Medicinal Products' (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the new Avandamet dosages of 1 gram metformin combined with 2 mg or 4 mg Avandia (rosiglitazone maleate) in the European Union. Avandamet (rosiglitazone maleate and metformin HCl) is a treatment for type 2 diabetes that combines two important medications in one convenient pill.

"GlaxoSmithKline is pleased with the positive opinion provided by the CHMP for the new Avandamet 1 gm tablets. We will soon be able to offer additional dosing flexibility and reduced pill burden for the many type 2 diabetes patients who are currently taking Avandamet or Avandia plus metformin," said Andrew Witty, president of GlaxoSmithKline Pharmaceuticals Europe.

"Over 60per cent of patients on traditional agents do not reach recommended treatment goals for blood sugar control putting them at risk of serious complications. The new dose combinations of rosiglitazone and metformin in one pill will soon offer patients an even more convenient way to reach currently recommended treatment goals for type 2 diabetes to achieve better diabetes management and sustain glycaemic control over the longterm," he added.

Avandamet is the first fixed-dose combination product that brings together Avandia, a thiazolidinedione, and metformin in one convenient pill. These two oral antidiabetics have different yet complementary mechanisms of action.

Avandamet was originally approved in the European Union in October 2003 for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are uncontrolled on their maximally tolerated dose of metformin alone.