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news.Novartis has received European Commission approval for the use of Galvus (vildagliptin) in patients with type 2 diabetes, who cannot take metformin.
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The approval is based on data from clinical studies, which have assessed the efficacy and tolerability of vildagliptin as monotherapy.
According to the study data, vildagliptin showed significant improvements in glycemic control and was generally well-tolerated.
Vildagliptin was demonstrated to be weight neutral and to be associated with a very low risk of hypoglycemia, the company said.
Galvus is already approved in the EU as an add-on to metformin for patients with type 2 diabetes.
Novartis, Primary Care global business franchise head Timothy Maloney said the approval for Galvus as a monotherapy provides the patients unable to take metformin with an effective and generally well-tolerated alternative.