Galvus Approved in EU as Monotherapy
The European Commission has approved the use of Galvus in patients with type 2 diabetes unable to control their blood sugar with diet and exercise alone and who cannot take metformin.
Novartis announced Monday that the European Commission has approved the use of Galvus (vildagliptin) in patients with type 2 diabetes unable to control their blood sugar with diet and exercise alone and who cannot take metformin, the current standard of care.
Approval is based on data from clinical studies in more than 3,000 patients, which have assessed the efficacy and tolerability of vildagliptin as monotherapy. In these studies, vildagliptin delivered significant improvements in glycemic control and was shown to be generally well-tolerated. Vildagliptin was demonstrated to be weight neutral and to be associated with a very low risk of hypoglycemia.
Galvus is already approved in the EU as an add-on t
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