Novartis seeks EU approval for oral diabetes treatment
Novartis has submitted Galvus (vildagliptin) for European approval for the treatment of type 2 diabetes. The company says the new, once-daily oral therapy has demonstrated impressive blood sugar lowering effects, even among difficult-to-treat patients who have poor glycemic control, are obese or older than 65.
Novartis has submitted Galvus (vildagliptin) for European approval for the treatment of type 2 diabetes. The company says the new, once-daily oral therapy has demonstrated impressive blood sugar lowering effects, even among difficult-to-treat patients who have poor glycemic control, are obese or older than 65.
Galvus works through a novel mechanism of action targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with type 2 diabetes. In clinical trials, treatment with Galvus was not associated with weight gain in the overall patient population - a key benefit for people with diabetes who struggle to keep their weight under control.
James Shannon, global head of development at Novartis Pharma said: "It is impossible to overstate the urgent need for new treatments that effectively lower blood sugar levels, while being well-tolerated, particularly in terms of their impact on body weight, gastrointestinal issues and hypoglycemia'.
Galvus was accepted for US regulatory review in March 2006.