Novartis' Galvus (vildagliptin), a new once-daily oral treatment for patients with type 2 diabetes, has been granted European Union approval. Galvus is the only drug in its class to offer such a broad range of indications for use in combination therapies with other anti-diabetic medicines.
This important approval for Galvus, which is a member of a new class of drugs known as DPP-4 inhibitors, comes as physicians are increasingly searching for new drugs to combine with existing medicines. The European Commission granted approval for Galvus to be used in combination with some of the most frequently prescribed oral anti-diabetes medicines - metformin, sulfonylureas (SUs) or thiazolidinediones (TZDs), the company announced in a press release.
The approval applies in all 27 countries of the European Union as well as in Norway and Iceland. The International Diabetes Federation (IDF) Diabetes Atlas estimates that approximately 28 million people in developed countries have type 2 diabetes, and more than half of patients with this disease are still not reaching their treatment goals despite undergoing medical treatment.
"The approval of Galvus is a major milestone for the millions of type 2 diabetes patients across Europe who are being treated but still not reaching optimal blood sugar levels," said Burkhard Göke, MD, Department of Gastroenterology at Ludwig-Maximilians-University in Munich, Germany.
"Galvus lowers high blood sugar levels with no weight gain and a low incidence of hypoglycaemia, two side effects commonly associated with currently available drugs such as SUs and TZDs. With Galvus, we now have another treatment option to help get patients to goal," said Dr. Göke.
Galvus delivers significant blood sugar reductions when used in combination with the most commonly used oral diabetes medicines in a range of type 2 diabetes patients. These include patients from varied ethnic groups, the elderly and those with uncontrolled blood sugar levels.
"We are delighted that Galvus is approved in Europe for patients with type 2 diabetes. Our rigorous clinical trial program has demonstrated the robust efficacy and tolerability of Galvus, which offers versatility to physicians looking for new treatment options," said James Shannon, MD, global head of development, Novartis Pharma AG.
Galvus is already approved in Brazil and Mexico. In February 2007, Novartis received an "approvable letter" from the US Food and Drug Administration (FDA). Novartis has submitted a proposal to the FDA for additional clinical studies in patients with renal impairment to confirm good tolerability in this patient group.
Galvus works through a novel mechanism of action by targeting the dysfunction in the pancreatic islets that cause high blood sugar levels in people with type 2 diabetes. Islet dysfunction, along with insulin resistance, is a contributory factor of type 2 diabetes, the company said.
In clinical trials, Galvus demonstrated an overall incidence of side effects similar to placebo. The most common side effects seen in the Galvus clinical program were stuffy nose, headaches, dizziness and upper respiratory tract infection.