Novo Nordisk submits application in the US for label addition for its diabetes drug
Novo Nordisk has submitted a supplemental application to the US Food and Drug Administration (FDA) for including data in the label for Tresiba (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven 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.