NOVARTIS SEEKS EUROPEAN APPROVAL FOR DIABETES DRUG

Swiss drugmaker Novartis has submitted Galvus (vildagliptin) for European approval for the treatment of Type 2 diabetes. Galvus is a once-daily oral therapy that has demonstrated significant blood sugar lowering effects, even among difficult-to-treat patients who have poor glycemic control, are obese or older than 65.

Galvus is a member of the DPP-4 inhibitor class and works by targeting the pancreatic islet dysfunction that causes high blood sugar levels in people with diabetes. In clinical trials, the drug was not associated with weight gain in the overall patient population — important for diabetes patients who struggle to keep their weight under control.

Phase III trials of Galvus have shown significant and consistent HbA1c reductions of up to 1.8 percent in poorly controlled patients when used as monotherapy. HbA1c is an important long-term measure of blood sugar control. Patients receiving Galvus in combination with other medicines in clinical trials were also more likely to reach their target blood sugar levels. In one study 65 percent of people reached their goal on a combination of Galvus and pioglitazone, while only 42 percent of patients achieved this goal on pioglitazone alone.