Pharma Times.com reported that Novartis’s Galvus has been approved by The European Commission in the use of patients with type 2 diabetes who cannot take metformin, which is the current standard of care.
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.
This approval 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.
This approval for Galvus is a significant one, as 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.