Vildagliptin is manufactured by Novartis as an anti diabetes medication. Vildagliptin was previously identified as LAF237, is a new oral hypoglycemic of the new dipeptidyl peptidase-4 inhibitor class of drugs. It is at present in clinical trials and has been shown to reduce or lessen hyperglycemia in type 2 diabetes mellitus

Vildagliptin was submitted to the U.S. FDA for approval, and will be sold as Galvus? by Novartis. Dipeptidyl peptidase-4's role in blood glucose regulation is thought to be through degradation of GIP and the degradation of GLP-1. Available Clinical Data Substantial new short and long term data is being submitted to US Food and Drug Administration.

Novartis had announced that three-month extension in the US regulatory review period for the oral anti-diabetes medicine vildagliptin until the end of February 2007 after deciding to submit recently available clinical data to the US Food and Drug Administration

These additional data being submitted to the FDA add about nearly 1,000 patient years of treatment experience with Vildagliptin. These recently available data include the results from short- and long-term studies for periods of up to two years, both as a monotherapy as well as in combination with other anti-diabetes medicines.

These new data further support the proposed dosing regimen and indications as well as complement the risk/benefit profile of Vildagliptin. In particular, they do provide further evidence confirming data submitted earlier to the FDA showing that skin findings identified in a single species during a preclinical animal study have not been seen in clinical studies with patients treated for type 2 diabetes.