GSK receives positive opinion for type 2 diabetes
GlaxoSmithKline has received a positive opinion from the EMEA CPMP for use of Avandamet (rosiglitazone maleate and metformin HCl) in the EU for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are uncontrolled on their maximally tolerated dose of metformin alone.
GlaxoSmithKline has received a positive opinion from the EMEA CPMP for use of Avandamet (rosiglitazone maleate and metformin HCl) in the EU for the treatment of type 2 diabetes mellitus patients, particularly overweight patients, who are uncontrolled on their maximally tolerated dose of metformin alone.
Avandamet will be the first treatment in Europe that combines a thiazolidinedione - Avandia (rosiglitazone maleate) - a medication that directly targets insulin resistance, a major underlying cause of type 2 diabetes, with a leading oral diabetes therapy, metformin, in one convenient pill. The complementary mechanisms of Avandia and metformin in Avandamet have been shown to provide superior glucose control in patients with type 2 diabetes versus metformin alone.1 The combination of Avandia plus metformin has been shown to have a low risk of hypoglycaemia, a side effect seen with some other traditional therapies. 2
References
1. Fonseca V, Rosenstock J, Patwardhan R, et al. Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. JAMA. 2000;283:1695-1702. 2. Jones TA, Sautter M, Van Gaal LF, et al. Addition of rosiglitazone to metformin is effective in obese, insulin-resistant patients with type 2 diabetes. Diabetes, Obesity & Metabolism 2003; 5:163-170.