Novartis seeks approval for new diabetes drug

Novartis is seeking EU approval for its new orally-administered drug for people suffering from type II diabetes.

The pharmaceutical says that Galvus has displayed properties of lowering blood sugar levels in several types of sufferer, such as those with poor glycemic control, those who are obese and those over the age of 65.

Phase III trials of the drug have shown “consistent reductions” in long-term blood sugar control, where HbA1c (a measure for blood sugar to) dropped to a value of around 1.8 per cent in patients used to monotherapy.

James Shannon, managing director and global head of development at Novartis, commented: “Diabetes is a serious chronic disease that is growing in prevalence worldwide. 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,” he added.

Galvus targets pancreatic islet dysfunction, which is responsible for high blood sugar levels in those affected by type II diabetes. Novartis states it improves the ability of both pancreatic alpha and beta cells to sense and respond appropriately to blood sugar levels.

Manufacturers say the drug has not been responsible for weight gain, which is of particular interest to diabetes sufferers who often struggle to keep their weigh under control.

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