Newly-released Phase III data for vildagliptin, the first of a new class of oral antidiabetic drugs known as dipeptidyl peptidase-IV (DPP-IV) inhibitors, show that the agent improves on currently-available therapeutic options in several respects.
Its developer, Swiss drug giant Novartis, claims vildagliptin also has the potential to prevent pre-diabetic patients developing Type 2 diabetes and the cardiovascular and metabolic complications of the disease. In addition, available data show that the agent avoids the gastrointenstinal side effects of metformin, as well as the weight-gain seen with thiazolidinediones, and it cuts insulin requirements by around half, thereby potentially providing significant advantages in treatment compliance.
Commenting on vildagliptin during the recent European Association for the Study of Diabetes meeting, Bo Ahren, Professor of Metabolic Research at Lund University said: “This drug is as important in terms of clinical practice as sulphonylureas and insulin were when they were introduced. It is the first drug that really has a chance of reversing the main defect in diabetes – the malfunctioning islet cells. Insulin is just a replacement therapy and sulphonylureas stimulate insulin secretion. But vildagliptin will actually improve the health of the islets. We need long term studies, of course, but if these confirm what we are seeing now, it really will be a breakthrough in diabetes.”
Novartis plans to present further pivotal clinical data on the drug in 2006, as well as file for approval in the USA. It will be submitted to the European regulatory authority in 2007. Merck and Bristol-Myers Squibb also have DPP-IV inhibitors in development.