Novartis has made an upbeat announcement regarding Phase III data on Galvus (vildagliptin), its oral DPP-4 inhibitor drug for type 2 diabetes, presented this week at the International Diabetes Federation meeting in Cape Town, South Africa.
New data from four pooled Phase III monotherapy trials in a broad type 2 diabetes population of up to 2,000 patients were presented. The trials, lasting from 12 to 52 weeks in patients taking an oral 100mg dose of Galvus daily, showed overall blood sugar reductions of 1% in HbA1C (a measure of long term blood glucose levels), and up to 1.8% in those with the highest baseline blood sugar levels. Of particular note was the finding that Galvus significantly reduced blood sugar amongst the over-65s, an age group where diabetes can be hard to control with oral treatments.
Furthermore, the new drug achieved results without an increased risk of side effects or weight gain – a problem that has dogged other drug classes for type 2 diabetes, with the exception of the old and often poorly-tolerated agent, metformin. Hypoglycaemia, a common problem for elderly patients, was rarely seen in Galvus studies.
Last month, the product’s progress was clouded by the announcement of a three-month delay in the time the US Food and Drug Adminstration will take to review its licensing application. The delay followed data supplied by Novartis on skin reactions to the drug that had been seen in preclinical, although not in clinical, studies, and puts Galvus even further behind Merck’s competitor DPP-4 inhibitor, Januvia, which is already available in the US.
Novartis remains bullish over Galvus' future
However, Novartis is bullish about Galvus’s future, saying it has repeatedly demonstrated promising efficacy and tolerability, especially among elderly patients, with no untoward effects seen in human trials. Patients over 65 represent a substantial proportion of the type 2 diabetes market. One in four of people over 60 are thought to have the condition although, in many, it remains undiagnosed for years.
The company claims Galvus can actually improve the core underlying problem in type 2 diabetes, namely dysfunctional pancreatic islet cells which secrete insulin. Galvus maintains insulin levels by regulating both the alpha cells and beta cells of the pancreas.
James Shannon, MD, Global Head of Development at Novartis Pharma AG said: “Galvus is the most widely studied DPP-4 inhibitor to date and is suitable for a broad range of patients with type 2 diabetes."
The FDA decision on Galvus is now expected in the first half of next year. Galvus was filed for approval in Europe in August 2006. By Olwen Glynn Owen