'Janumet'TM (Sitagliptin/Metformin) Approved In The European Union For Treatment Of Type 2 Diabetes
The product is now approved by the 27 member countries of the European Union (EU) to improve glycaemic control in patients with type 2 diabetes inadequately controlled on diet and exercise plus their maximally tolerated dose of metformin alone, or those already being treated with the combination of sitagliptin and metformin. Janumet is also approved for use in combination with a sulphonylurea (SU) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and an SU. With this approval, Janumet is now approved in more than 50 countries worldwide and more than one million total prescriptions have been dispensed.1 Following marketing authorisation, product launch times may vary from country to country.
The approval of this new combination treatment follows the European Medicines Agency's (EMEA) recent listing of DPP-4 inhibitors, including sitagliptin, as a medicine of notable public health interest.
"We are very pleased to receive European approval of Janumet and the recent recognition by the EMEA of the important role that DPP-4 inhibitors can play in the management of type 2 diabetes. With 53 million people in Europe living with type 2 diabetes, and a substantial proportion not achieving blood glucose goal, this combination provides physicians with an effective new option to help patients manage their blood glucose levels," said Stefan Oschmann, President, Europe, Middle East, Africa and Canada, Merck & Co., Inc.
The combined mechanisms of the two agents in Janumet target all three core defects associated with type 2 diabetes. The sitagliptin component in the combination increases the levels of active incretins, thereby enhancing a natural body process that increases insulin synthesis and release from pancreatic beta cells and lowers glucagon secretion from pancreatic alpha cells, leading to reduced production of glucose by the liver. Metformin, a mainstay of diabetes therapy, targets insulin resistance by increasing the uptake and utilization of glucose. Metformin also decreases production of glucose by the liver in a manner that is complementary to sitagliptin.
Janumet provides powerful glucose lowering
In a 24-week, randomised, double-blind, placebo-controlled study with 701 patients with mildly to moderately elevated HbA1c levels (mean baseline 8.0 percent) inadequately controlled on metformin, patients taking sitagliptin (n=453) experienced a significant additional mean placebo-subtracted reduction in HbA1c of 0.7 percent beyond that achieved by patients who continued on metformin alone (n=224) (p
"Janumet'TM (Sitagliptin / Metformin) a aprobat în Uniunea Europeanã pentru tratamentul diabetului de tip 2 - 'Janumet'TM (Sitagliptin/Metformin) Approved In The European Union For Treatment Of Type 2 Diabetes - articole medicale engleza - startsanatate