Galvus® – a revolutionary treatment for type 2 diabetes
On March 30, Novartis announced that the new drug application for Galvus was accepted for review by the 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.
In clinical studies, Galvus has demonstrated significant reductions in blood sugar, sustained 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, 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.
About diabetes
On March 30, Novartis announced that the new drug application for Galvus was accepted for review by the 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.
In clinical studies, Galvus has demonstrated significant reductions in blood sugar, sustained 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, 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.
About diabetes
- In most developed nations, diabetes is the fourth leading cause of death.
- Diabetes currently affects about 195 million people worldwide and is estimated to grow to more than 330 million by 2025.
- While the disease burden among Western nations is great, it is estimated that, in the developing world, the cases of type 2 diabetes will increase by 170% by 2025.
- Type 2 diabetes is a progressive disease, where control of blood sugar deteriorates over time.
- Diabetes can lead to heart and kidney disease, blindness, and vascular or neurological problems, which can result in amputation.
- More than half of those currently taking medication to manage their diabetes are still not reaching their blood sugar goals.