ZURICH, Feb 25 (Reuters) - The European Union approved Novartis’s NOVN.VX Eucreas diabetes pill, the Swiss drugmaker said on Monday, following its approval of Galvus, one of the two-in-one drug’s ingredients.
Eucreas combines Galvus — a member of the so-called DPP-4 inhibitors associated with liver problems — and metformin, which decreases the production of sugar by the liver, and increases insulin sensitivity.
“The approval comes after Novartis proposed changes to the EU label recommending that liver monitoring should be conducted,” Novartis said in a statement.
The European Medicines Agency said in September it had backed Eucreas to treat type-2 diabetes, the most common form of the disease. The Agency’s recommendations are normally followed by approval in the 27-nation bloc.
The EU approved Galvus — which had been expected to garner over $1 billion in sales before its safety issues became apparent — on Feb. 1 after Novartis said the label for the drug should warn for liver problems.
DPP-4 inhibitors enhance the body’s own ability to lower elevated blood sugar and could become an important new way to control diabetes. They are not associated with weight gains, a drawback in many other diabetes medicines. (Reporting by Douwe Miedema)