The European Commission has approved Galvus (vildagliptin), an oral treatment, for type 2 diabetes patients.
The approval applies to all 27 countries of the European Union, as well as Norway and Iceland. It follows changes to the EU label proposed by the manufacturer, Novartis, regarding the administration of the drug.
The Commission has approved the use of Galvus in combination with some of the most commonly prescribed oral anti-diabetes drugs – metformin, sulphonylureas (SU), or thiazolidinediones (TZD).
“The approval of Galvus allows us to move forward with making this important new treatment option available to patients in Europe with type 2 diabetes,” said James Shannon, MD, Chief Medical Officer at Novartis Pharma AG.
“In clinical trials, Galvus has been shown to provide additional efficacy when used in combination with most currently prescribed anti-diabetes medicines across a broad range of patients.”
Nearly 13,000 patients have been administered Galvus in the clinical trial programme. When studied in combination with the most widely prescribed type 2 diabetes medicines, the Galvus reduced blood sugar with positive tolerability in a broad range of patients.
The overall incidence of side effects was similar to the placebo, with the most common being stuffy nose, headaches, dizziness and upper respiratory tract infection.