European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Sep 26 2009

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA^® tablets and JANUMET^® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes. If adopted by the European Commission, sitagliptin will be the only diabetes treatment in the DPP-4 inhibitor class to have an indication for use as add-on to insulin in the European Union.

In the United States, JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. JANUMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. JANUMET and JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The labeling for both JANUVIA and JANUMET state that they have not been studied in combination with insulin.

In the United States, a supplemental New Drug Application (sNDA) that is similar to the European proposal concerning the use JANUVIA and JANUMET in combination with insulin has been accepted by the U.S. Food and Drug Administration (FDA) and is currently under review. The use of JANUVIA and JANUMET in combination with insulin is investigational in the U.S.

Sitagliptin is a selective, once-daily DPP-4 inhibitor that enhances a natural body system called the incretin system to help regulate blood sugar by increasing levels of active GLP-1 and GIP hormones; it inhibits DPP-4 over 24 hours. The fixed-dose combination of sitagliptin and metformin targets all three key defects of diabetes: insulin deficiency from pancreatic beta cells, hepatic insulin resistance, and overproduction of glucose by the liver. Sitagliptin is the first approved medicine in the DPP-4 inhibitor class of oral treatments. It has been approved in more than 80 countries, and to date there have been more than 15 million prescriptions dispensed worldwide.

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