GalvusTreatment for Diabetes Type 2
New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA
Clinical studies show significant blood sugar reductions (HbA1c) sustained for one year
EAST HANOVER, N.J., March 30, 2006 -- Novartis announced today that the new drug application (NDA) for Galvus* (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 prevalence of diabetes is increasing and more than half of the people who are currently taking diabetes medications are still not reaching their blood sugar goals," said James Shannon, MD, Head of Development at Novartis Pharma AG. "Galvus may represent an exciting new option for the treatment of type 2 diabetes with the potential of helping patients reach and maintain their treatment goals with good tolerability."
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."
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.
Diabetes currently affects about 195 million people worldwide and is estimated to grow to more than 330 million by 2025, according to the International Diabetes Federation. The U.S. Centers for Disease Control estimates that about 20 million Americans have diabetes.
Type 2 diabetes is a progressive disease where control of blood sugar deteriorates over time. It is the sixth leading cause of death in the U.S. and a major contributor to heart disease, stroke, blindness, kidney disease and vascular or neurological problems that can result in amputation.
Islet dysfunction and the body's resistance to insulin both contribute to diabetes. Specifically, islet dysfunction can lead to excess sugar production (via glucagon from the alpha-cells) and reduced insulin production (from the beta-cells). Even among people receiving diabetes care, controlling blood sugar levels is difficult. More than half of those currently taking medication to manage their diabetes are still not reaching their blood sugar goals, according to data from the National Health and Nutrition Examination Survey (NHANE).
Posted: March 2006
- Novartis Committed to Making Galvus Available for Patients with Type 2 Diabetes After US Regulators Issue ''Approvable Letter'' - February 26, 2007
- Novartis announces three-month extension of US regulatory review for Galvus to assess recently available clinical data - November 13, 2006