European health authorities have approved Eucreas, an oral tablet combining Galvus (vildagliptin) and metformin, as a new treatment for patients with type 2 diabetes.
Eucreas is the first single-tablet combination of a member of the new DPP-4 inhibitor class with metformin to be approved in the European Union (EU).
The approval comes after manufacturer Novartis proposed changes to the EU label recommending that liver monitoring should be conducted at the start of treatment, every three months for the first year, and periodically thereafter. The Eucreas approval closely follows European approval of the updated label for Galvus announced earlier this month.
The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and both medicines will be available in the first European countries within the next few weeks.
Studies show that more than half of patients currently taking medication to manage their type 2 diabetes are still not reaching blood glucose goals. Combination therapy usually becomes necessary due to progressive worsening of blood sugar control during the natural course of the disease.
In clinical studies, patients inadequately controlled on metformin, one of the most prescribed oral therapies for type 2 diabetes, were four times more likely to achieve blood sugar control by adding Galvus to their treatment compared to those who added a placebo (or sugar pill). Furthermore, Galvus when administered with metformin resulted in additional blood sugar reductions of 1.1% as measured by HbA1c, the gold standard measure of blood sugar control.
“The approval of Eucreas marks an important step forward in the management of type 2 diabetes, as it is the first single-tablet combination of a DPP-4 inhibitor with metformin for patients in Europe,” said James Shannon, MD, Chief Medical Officer at Novartis Pharma AG.
“The complementary actions of Galvus and metformin, which are the medicines combined in Eucreas, help to bring blood sugar levels under control without the side effects commonly associated with many widely-used type 2 diabetes medicines.”