Updated labeling for Tresiba recommended by CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed an update of the European Union label with immediate effect for Tresiba(insulin degludec) to include results from the DEVOTE trial on severe hypoglycemia, Danish diabetes care giant Novo Novartis (NOV: N) announced this afternoon.

DEVOTE is a randomized, multinational and double-blinded trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.

When Novo Nordisk first presented the DEVOTE trial results in June, analysts suggested that the real world superior clinical trial statistics could significantly boost the marketing capabilities of Tresiba around the world.