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.

The company explained that in the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba compared to insulin glargine U100. The trial thereby confirmed the results of the DEVOTE interim analysis submitted to the FDA in March 2015, on the basis of which Tresiba and Ryzodeg 70/30 were approved in the US in September 2015.

“The risk of severe hypoglycaemia is a major cause for people with type 2 diabetes not reaching their treatment targets,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “However, with the DEVOTE data, we have demonstrated that the strong clinical profile of Tresiba leads to a significant reduction in severe hypoglycaemia in people with type 2 diabetes.”