Posted by Michael Wonder on 02 Oct 2017
CHMP endorses Tresiba label update in the EU - new label reflects significant reduction in the risk of severe hypoglycaemia
29 September 2017 - Novo Nordisk today announced that the CHMP, under the EMA, has endorsed an update of the EU label with immediate effect for Tresiba (insulin degludec) to include results from the DEVOTE trial on severe hypoglycaemia.
DEVOTE is a randomised, multinational and double-blinded 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 mellitus.
