European health authorities have approved Galvus (vildagliptin) as a new oral treatment for type 2 diabetes patients, paving the way for launches in Europe. This regulatory approval applies in all 27 countries of the European Union as well as in Norway and Iceland and comes after changes updating the EU label were proposed by Novartis regarding the administration of Galvus.
The European Commission approved Galvus for use in combination with some of the most frequently prescribed oral anti-diabetes medicines - metformin, sulphonylureas (SU), or thiazolidinediones (TZD). Galvus can be prescribed as 50 mg once-daily in combination with an SU, or 50 mg twice-daily in combination with metformin or a TZD.
Galvus is not recommended for patients with liver impairment, and liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. Due to limited experience, Galvus is not recommended for patients with moderate or severe renal impairment or congestive heart failure. Galvus should not be used in patients with type 1 diabetes.
"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".
Over 20,000 patients have participated in the Galvus clinical trial program to date, including nearly 13,000 treated with Galvus. When studied in combination with the most widely prescribed type 2 diabetes medicines, Galvus delivered significant blood sugar reductions with a positive tolerability profile in a broad range of patients. The overall incidence of side effects was similar to placebo with the most frequent being stuffy nose, headaches, dizziness and upper respiratory tract infection.
As a member of the new class of DPP-4 inhibitors, Galvus works through a novel mechanism of action by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes. Islet dysfunction, along with insulin resistance, is a contributory factor to type 2 diabetes, a progressive disease in which control of blood sugar deteriorates over time.
Controlling blood sugar levels is difficult even among patients receiving treatment, and more than half of patients with type 2 diabetes currently taking medicines are still not reaching their blood sugar goals. When left untreated or not kept under control, type 2 diabetes can lead to heart and kidney disease, blindness, and vascular or neurological problems.