Shares in Novo Nordisk (NYSE:NVO) were up 2% this morning after the European Medicines Agency’s Committee for Medicinal Products for Human Use backed the company’s application for a label update to its Tresiba insulin injection.
The company submitted an application in November to add data from 2 studies to the medication’s label. The final ruling is expected to come from the committee in 60 days.
Nordisk requested that data from trials Switch I and Switch II be included on Tresiba’s label. In the Switch I study, patients with Type I diabetes who received Tresiba in combination with insulin aspart had 11% fewer hypoglycemic episodes that those receiving insulin glargine and insulin aspart. They also experienced 36% fewer episodes of nocturnal hypoglycemia and 35% fewer episodes of severe hypoglycemia than their counterparts.
In the Switch II study, patients with Type II diabetes that were treated with Tresiba and oral antidiabetic drugs had fewer episodes of hypoglycemia, and nocturnal hypoglycemia compared to patients who received insulin glargine and oral antidiabetic drugs.
Both studies also reportedly demonstrated that Tresiba was non-inferior to insulin glargine according to blood glucose level reduction.
In November, Nordisk said that data from the Devote clinical trial indicated that its injected insulin, Tresiba, reduced the risk of severe hypoglycemia when compared to insulin glargine.
The trial enrolled more than 7,500 Type II diabetes patients at high risk of adverse cardiovascular events and treated them for 2 years with either Tresiba or insulin glargine U100. The long term analysis sought to confirm interim data that the Denmark-based company used to support its FDA approval for Tresiba in September last year.
The Devote trial met its primary endpoint, demonstrating non-inferiority of major adverse cardiovascular events with the injected insulin degludec compared to insulin glargine. There was no statistical difference between the 2 treatments and their safety profiles, the company reported.