FDA Approves Updated Label for Tresiba

The US Food and Drug Administration (FDA) has approved an updated label to now include new cardiovascular safety data in US prescribing information for Tresiba (insulin degludec) based on the results of a recent trial.

The DEVOTE trial, which included 7637 adults with type 2 diabetes and high cardiovascular risk, showed that treatment with Tresiba was associated with 40% lower rate of severe hypoglycemia compared with insulin glargine U100.

Findings also indicated that Tresiba was non-inferior to insulin glargine U100 in regard to major adverse cardiovascular events (hazard ratio 0.91).

The Tresiba label was updated to reflect this data regarding safety outcomes and cardiovascular safety, as well as data on severe hypoglycemia.

"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, in a press release. "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."

Tresiba received its first regulatory approval in September 2012. 

—Christina Vogt

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