Novartis' Galvus NDA accepted by FDA

Swiss major Novartis says that the US Food and Drug Administration has accepted a New Drug Application for Galvus (vildagliptin), the firm's developmental oral treatment for type 2 diabetes. The compound tagets pancreatic islet dysfunction through inhibiton of the dipeptidylpeptidase 4 enzyme which, in sufferers, is reponsible for elevated blood sugar levels. The product also mediates an increase in the sysnthesis of insulin, resulting in improved blood sugar regulation.

The NDA is based on data from a clinical trial of the drug in 4,300 patients which assessed it as both a monotherapy and in combination with other antidiabetic agents. The data showed that the compound produced a clinically-significant reduction in HbA1c levels after one year of use. Additionally, the firm says that the drug was well-tolerated and did not cause the weight gain associated with other currently-available treatments. The company says it also intends to submit Galvus to European regulatory authorities later this year.