That didn’t take long. Just a few days after unveiling new cardiovascular data for long-acting insulin Tresiba, Novo Nordisk has made moves to get them added to the medication’s label.
The Danish drugmaker has submitted an application to the European Medicines Agency asking the regulator to add the results from the Devote trial, which pitted newcomer Tresiba against stalwart Lantus from Sanofi, to Tresiba’s label. And if Novo can snag an OK, it’ll help level the playing field against its competition.
Devote results, announced on Monday at the American Diabetes Association’s annual meeting in San Diego, showed that high-risk Type 2 diabetes patients taking Tresiba were no more likely to suffer a major cardiovascular event—such as heart attack or stroke—than those using Lantus were.
That fact alone marked a win for Novo, which initially saw Tresiba rejected in the U.S. over heart-safety concerns. Interim Devote results helped allay fears, though, and the FDA ultimately approved the med.
CV safety data wasn’t all to come out of Devote, though, and the Novo drug managed to score a couple of wins against its rival, too. Tresiba patients saw their rate of severe hypoglycemia plunge by 40%, and the product also reduced nighttime episodes of severe hypoglycemia by 53%.
“Especially in this population with higher CV risks, you do not want these individuals to have a severe episode, so really trying to avoid those is paramount to your insulin therapy,” Todd Hobbs, M.D., Novo’s North American chief medical officer, said in an interview. “Those kinds of reductions—roughly half—makes a difference.”
Europe likely won’t be alone for long in having received a filing related to the data. “Certainly we’ll talk to the FDA about what this means from a labeling perspective,” Hobbs said.