FDA Accepts New Drug Application for Diabetes Drug Galvus

Clinical studies show significant blood sugar reductions (HbA1c) sustained for one year – Trials also show no association with weight gain; overall incidence of side effects, including hypoglycemia and edema, similar to placebo – Regulatory submission includes results from more than 4,300 patients.

Novartis announced today that the new drug application (NDA) for Galvus(R)* (vildagliptin, formerly LAF237) was accepted for standard review by the U.S. Food and Drug Administration (FDA). If approved, Galvus will provide a new, once-daily oral treatment option for people with type 2 diabetes. Submission for approval in Europe is on track to be completed later in 2006.

Galvus, a DPP-4 inhibitor, works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. Galvus affects both pancreatic alpha and beta cells, leading to a reduction in sugar production from the liver together with an increase in production of insulin needed to keep blood sugar under control.

The submission includes data from clinical trials involving more than 4,300 patients worldwide evaluating the use of Galvus as monotherapy and also in combination with commonly prescribed anti-diabetic agents. Galvus is suitable for once-daily dosing. Overall, Galvus has shown clinically significant HbA1c reductions out to one year of treatment, with good overall tolerability and without causing weight gain. The most common side effects were cold-like symptoms, headache and dizziness.

"Most of the treatments that we use today focus primarily on stimulating insulin secretion or lowering resistance," said Vivian Fonseca, MD, Professor of Medicine, Chief of Endocrinology and Metabolism, Tulane University Health Sciences Center, New Orleans, Louisiana. "The positive clinical results we’ve seen to date with Galvus underscore the importance and promise of addressing the dysfunction of both the pancreatic beta- and alpha-cells."
About Galvus

In clinical studies, Galvus has demonstrated significant reductions in blood sugar for one year. Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. Galvus was not associated with overall weight gain, a key benefit for people with diabetes who struggle to keep their weight under control. The overall incidence of side effects with Galvus including hypoglycemia (excessively low blood sugar) and edema (fluid retention) was similar to placebo. Galvus lowers blood sugar by targeting islet dysfunction, i.e., it improves the ability of the islet’s alpha- and beta-cells to appropriately sense and respond to sugar in the blood. Looks like vildagliptin (LAF237)is the current leader over sitaglitpin (MK-0431) and saxagliptin (BMS-477118)

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