European regulators have given the green light to Novartis’ new combination diabetes drug Eucreas, which contains the firm’s recently-approved dipeptidyl peptidase-4 (DPP-4) inhibitor Galvus.
Eucreas combines Galvus (vildagliptin) and metformin and the approval comes after Novartis proposed changes to the label recommending that liver monitoring should be conducted at the start of treatment, “every three months for the first year and periodically thereafter”, the Basel-based firm said. Eucreas is the first single-tablet combination of the DPP-4 inhibitor class with metformin to be approved in the European Union and the decision applies in all 27 countries of the EU as well as in Norway and Iceland.
The Eucreas green light closely follows European approval of the updated label for Galvus which was announced earlier this month. James Shannon, chief medical officer at Novartis Pharma, said that “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”.
Now that Galvus and Eucreas are available in Europe, Novartis can now take on Merck & Co’s rival product Januvia (sitagliptin) and analysts believe that peak sales could be in the region of $500 million. It needs to perform well in the Old Continent because the US Food and Drug Administration earlier this year requested more data in an approvable letter and chief executive Daniel Vasella said Novartis may choose not to pursue US regulatory approval if the agency’s demands for new studies prove excessive.
