Novo Nordisk (NYSE:NVO) said today that it submitted a supplemental application to the FDA, asking to include cardiovascular data on the label of its Tresiba insulin degludec.
The Danish insulin-maker asked to include data specifically from the Devote trial, which evaluated the cardiovascular safety of Tresiba compared to insulin glargine in patients with Type II diabetes.
The Devote trial met its primary endpoint after Tresiba demonstrated non-inferiority for major adverse cardiovascular events compared to insulin glargine. The trial was consistent with interim results submitted to the FDA in March 2015, which helped support Tresiba’s initial approval in September of that year.
The company added that Tresiba performed better on the trial’s secondary endpoint – 27% fewer patients in the Tresiba group had an episode of severe hypoglycemia, which contributed to a 40% drop in total episodes of adjudicated severe hypoglycemia. Patients in the Tresiba arm also experienced a 54% relative cut in the rate of nocturnal severe hypoglycemia, according to Novo Nordisk.
“The risk of severe hypoglycaemia is a major cause for people with Type II diabetes not reaching their treatment targets,” executive VP & chief science officer Mads Krogsgaard Thomsen said in prepared remarks. “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 II diabetes.”