Posted by Michael Wonder on 30 May 2017
Novo Nordisk submits application in the US for including data from the DEVOTE trial in the Tresiba label
27 May 2017 - Novo Nordisk today announced the submission of a supplemental application to the US FDA for including data in the label for Tresiba (insulin degludec) from the DEVOTE trial, a long-term, randomised, double-blinded and event-driven trial conducted to confirm the cardiovascular safety of Tresiba compared to insulin glargine U100 when added to standard of care, in people with type 2 diabetes.
In the DEVOTE trial, the primary endpoint was achieved by demonstrating non-inferiority of major adverse cardiovascular events (MACE) with Tresiba compared to insulin glargine U100. The trial thereby confirmed the results of the DEVOTE interim analysis submitted to the FDA in March 2015, on the basis of which Tresiba and Ryzodeg 70/30 were approved in the US in September 2015.
The DEVOTE trial has been conducted in response to a Complete Response Letter received from the FDA in February 2013 requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications for Tresiba and Ryzodeg 70/30 could be concluded. Tresiba and Ryzodeg 70/30 were approved in the US in September 2015 on the basis of an interim analysis of DEVOTE.
