FDA Approves Updated Tresiba Label

The US Food and Drug Administration (FDA) has approved the inclusion of new cardiovascular safety data from the DEVOTE trial in US prescribing information for Tresiba (insulin degludec).

The DEVOTE trial, which included 7637 adults with type 2 diabetes and high cardiovascular risk, showed that treatment with Tresiba was associated with 40% lower rate of severe hypoglycemia compared with insulin glargine U100.

Findings also indicated that Tresiba was non-inferior to insulin glargine U100 in regard to major adverse cardiovascular events (hazard ratio 0.91).

The Tresiba label was updated to reflect this data regarding safety outcomes and cardiovascular safety, as well as data on severe hypoglycemia.

—Christina Vogt

Reference:

FDA approves inclusion of data on cardiovascular outcomes and severe hypoglycaemia in the Tresiba label [press release]. Bagsværd, Denmark. Novo Nordisk. March 26, 2018. https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2179392.html. Accessed on March 27, 2018.