Novo Nordisk Asks FDA to Update Tresiba Label on Hypoglycemia

While regulators long ago saw enough cardiovascular safety data to approve insulin degludec, full trial results will be presented June 12 at the American Diabetes Association Scientific Sessions in San Diego.

Novo Nordisk has filed a supplemental application with FDA, seeking to add data to the label of insulin degludec, sold as Tresiba, that show the product offers patients with type 2 diabetes (T2D) a lower risk of severe hypoglycemia.

Data from the DEVOTE trial, a head-to-head study that compared cardiovascular safety of insulin degludec and insulin glargine, show that 27% fewer patients using insulin degludec experienced severe hypoglycemia compared with those in the insulin glargine group.

Insulin degludec, one of the newer ultra long-acting insulins, also cut the risk of severe hypoglycemia at night by 54% relative to insulin glargine. Those with advanced T2D most fear hypoglycemia at night, when they might not realize they are experiencing symptoms.

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

In February 2013, FDA ordered Novo Nordisk to conduct a cardiovascular safety trial for insulin degludec following the fallout over rosiglitazone. Sold as Avandia, the drug became a blockbuster until a study in the New England Journal of Medicine raised questions whether those taking the drug were at higher risk of heart attacks. While the FDA ultimately cleared rosiglitazone, the saga paved the way to new protocols that require diabetes and obesity therapies to prove they are safe for those with at high risk of heart attacks or stroke.

Insulin degludec’s approval in September 2015 (along with an Insulin degludec/insulin aspart combination called Ryzodeg) meant that FDA had seen enough data to show that the drug was safe. Full data from DEVOTE will be presented during the 77th Scientific Sessions of the American Diabetes Association on June 12, 2017, in San Diego, California.