Merck & Co gains EU appro for Janumet

27 July 2008

US drug major Merck & Co has been granted European marketing authorization for type 2 diabetes treatment Janumet (sitagliptin/metformin).

The product is now approved by the 27 member countries of the European Union to improve glycemic control in patients with type 2 diabetes inadequately controlled by 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, in combination with a sulfonylurea, as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and an SU.

The firm says its product has a low risk of weight gain and hypoglycemia compared with metformin alone and targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells; insulin release; and overproduction of glucose by the liver.

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