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FDA approval for Novo’s prescribing information for Tresiba


The US Food and Drug Administration (FDA) has approved an update to the US prescribing information for Tresiba (insulin degludec) to include data from the DEVOTE trial.

The DEVOTE trial included 7,637 adults with type 2 diabetes at high cardiovascular risk and demonstrated non-inferiority of Tresiba compared to insulin glargine U100 with regards to major adverse cardiovascular events (MACE) with a hazard ratio of 0.91. MACE was defined as first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.

As a pre-specified secondary end-point, treatment with Tresiba resulted in 40% statistically significant lower rate of severe hypoglycaemia compared to insulin glargine U100. The glycaemic control between the two groups was similar at baseline and throughout the trial. The Tresiba label was updated to reflect safety outcomes from the trial, the cardiovascular safety as well as the severe hypoglycaemia data.

Updated label

Furthermore, supplemental applications were submitted to the FDA in September 2016 for including data from the two SWITCH phase 3b trials in the label for Tresiba. Following interactions with FDA, Novo Nordisk has withdrawn the applications related to the data from the SWITCH trials.

“It is well known that the fear of severe hypoglycaemia is a barrier to achieving good glycaemic control for many people with diabetes,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are therefore very pleased that the FDA has approved the updated label for Tresiba as the only basal insulin to be labelled with a lower rate of severe hypoglycaemia compared to insulin glargine U100.”

The EU label for Tresiba was updated in 2017 to reflect both the cardiovascular outcomes as well as the severe hypoglycaemia data of this long-acting basal insulin.