Novartis' Eucreas cleared in EU

The European health authorities have approved Swiss drug major Novartis' 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 dipeptidyl-peptidase 4-inhibitor class with metformin to be approved in the European Union, the company states. The firm's share price edged up 0.5% to 54.60 Swiss francs on the news, released February 25.

The approval comes after 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 product's clearance closely follows European approval of the updated label for Galvus announced earlier this month.

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.