The European Commission has approved the use of Novartis' Galvus in patients with type 2 diabetes who cannot take metformin, the current standard of care.

This latest green light for Galvus (vildagliptin) is based on data from clinical studies in more than 3,000 patients, which have assessed the drug as monotherapy. In these studies, the treatment delivered significant improvements in glycaemic control and was shown to be generally well-tolerated, as well as weight neutral and associated with a very low risk of hypoglycaemia.

Galvus is already approved in the European Union as an add-on to metformin, sulphonylureas and thiazolidinediones and in the last quarter, it also received a thumbs-up  for Galvus for use in patients with type 2 diabetes and moderate or severe renal impairment.

The latest approval for Galvus, which is a dipeptidyl peptidase IV (DPP-4) inhibitor, is a significant one. Novartis notes that more than 47 million people have type 2 diabetes in Europe,  a figure which is set to rise to 57 million by 2030 and a quarter of those being treated cannot take metformin due to intolerance or contraindications.

Galvus set to be a blockbuster soon

Novartis believes that Galvus will be one of the drugs that will offset the loss of revenues from patent expirations, notably on its biggest-seller, the blood pressure lowerer Diovan (valsartan). In 2011, Galvus generated sales of $677 million, a rise of 66% and this despite not being available in the USA.

When the Swiss major's financials for the full-year came out last month, David Epstein, head of Novartis Pharma, said the Galvus franchise "continues to be under-appreciated by the market". He noted that in six countries despite launching second behind Merck & Co's huge-selling Januvia (sitagliptin), "we are now the market leader in the DPP-4 space" and approval has just been garnered in China. "This brand should be a blockbuster, we believe, quite soon," he added.