Novartis announced that the company has submitted Galvus (vildagliptin) for European approval for the treatment of type 2 diabetes. Galvus is a new, once-daily oral therapy that 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.
"Diabetes is a serious chronic disease that is growing in prevalence worldwide," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "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 hypoglycaemia. The results reported from the robust Galvus clinical trial program and included in the European filing demonstrate that Galvus may be a powerful new tool for people with diabetes."
Phase III trials for Galvus have shown significant and consistent HbA1c reductions of up to -1.8 per cent in poorly controlled patients when used as monotherapy. HbA1c is an important long-term measure of blood sugar control. Significant blood sugar reductions with Galvus have been sustained for one year.
Patients receiving Galvus in combination with other medicines in clinical trials were also more likely to reach their target blood sugar levels (i.e. HbA1c less than or equal to 7 per cent). In one study 65 per cent of people reached their goal on a combination of Galvus and pioglitazone, while only 42 per cent of patients achieved this on monotherapy on pioglitazone.
"The treatment of type 2 diabetes is still largely unsatisfactory, with an excessive proportion of patients outside the ideal goal," commented Professor Emanuele Bosi, director of the Diabetes & Endocrinology Unit, San Raffaele University Hospital, Milan, Italy. "Vildagliptin is a new drug with a novel mechanism of action, potentially able to counteract the spontaneous and progressive worsening of the disease."
He continued: "The impact vildagliptin may have on diabetes treatment is potentially significant. Patients taking vildagliptin in clinical trials benefited from its ability to both stimulate insulin production and inhibit glucagon secretion, restoring a normal balance between the two that results in better blood sugar control, with a low risk of hypoglycaemia and no weight gain."
Galvus is a member of the DPP-4 inhibitor class and works by targeting pancreatic islet dysfunction. In people with type 2 diabetes, this can lead to excess sugar production (via glucagon from the alpha-cells) and reduced insulin production (from the beta-cells). Galvus affects both pancreatic alpha and beta cells, improving their ability to appropriately sense and respond to sugar in the blood.
Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. The effect on weight is important for many people with diabetes. In one head-to-head comparison with rosiglitazone, an insulin sensitizer, Galvus-treated patients saw a mean reduction of body weight greater than 1 kg, with an overall mean difference of 2.8 kg between the Galvus and rosiglitazone treatment groups. This weight loss was achieved with blood sugar lowering efficacy comparable to rosiglitazone.
The overall incidence of side effects with Galvus, including hypoglycaemia (excessively low blood sugar), gastrointestinal intolerance and edema (fluid retention), was similar to placebo in monotherapy trials. The most common side effects seen in the Galvus clinical program were cold/flu-like symptoms, headaches and dizziness.
The Galvus EU regulatory submission is based on a robust clinical development program containing data from more than 5,400 patients. Galvus was accepted for US regulatory review in March 2006.