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news.Novartis has submitted an application to European regulators seeking approval for Galvus, its oral treatment for type 2 diabetes. If approved in the major markets, Galvus is tipped to achieve blockbuster status.
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Novartis said its application was based on a clinical development program containing data from more than 5,400 patients. The drug was accepted for US regulatory review in March 2006.
In clinical trials Galvus has demonstrated impressive blood sugar lowering effects, even among difficult-to-treat patients who have poor glycemic control, are obese or older than 65. In addition, 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.
According to the company, 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.
“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. 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,” said Dr James Shannon, Global Head of Development at Novartis Pharma AG.