The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product.
The Danish insulin-maker evaluated its Type II diabetes drug in a 7,637-patient trial, assessing the therapy for cardiovascular safety compared to insulin glargine.
Novo Nordisk’s 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.
Tresiba’s new label will include a statement that the product demonstrated no increase in risk for major adverse cardiovascular events compared to insulin glargine and demonstrated a 40% lower rate of severe low blood sugar.
“Tresiba is clinically proven to lower patients’ A1C levels, and now the updated label provides physicians with additional clinical evidence to help guide treatment decisions,” Todd Hobbs, Novo Nordisk’s VP & U.S. CMO, said in prepared remarks.
“Cardiovascular disease and severe hypoglycemia are two of the most profound concerns for people living with diabetes. Novo Nordisk is dedicated to research in these areas and believes in their importance to overall diabetes care,” he added.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.