Posted from: Wednesday, May 16, 2018 - 03:58 PM - Present

Tresiba Receives New Labeling

March 26, 2018 – The U.S. FDA has approved changes to the label for Novo Nordisk’s Tresiba® (insulin degludec). The label will now indicate that Tresiba may reduce the risk of severe hypoglycemia by 40% compared to insulin glargine, and does not increase the risk of adverse cardiovascular events compared to insulin glargine.

The new label may help Tresiba compete against insulin glargine, which is available under the brand names Lantus®, Toujeo®, and Basaglar®, in the U.S. market. Severe hypoglycemia significantly raises the risk of death for patients with type 2 diabetes, and can increase the need for emergency room visits and hospital stays. Tresiba is a long-acting insulin indicated to control blood sugar levels in patients who are at least one month of age.

According to an earnings report released by Novo Nordisk, Tresiba’s annual sales had totaled $800 million by the third quarter in 2017. The drug was launched in February of 2016.

 

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Last Updated Friday, September 21, 2018 - 10:21 PM.