Posted by Michael Wonder on 15 Jun 2017
Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba label
14 June 2017 - Novo Nordisk today announced the submission of a type II variation application to the EMA 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 when added to standard of care, in people with type 2 diabetes.
