full announcement

14 Jun 2017 13:03 CET

Novo Nordisk submits application in the EU for including data from the DEVOTE trial in the Tresiba® label

Bagsværd, Denmark, 14 June 2017 - Novo Nordisk today announced the submission of a Type II Variation application to the European Medicines Agency (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 U100 when added to standard of care, in people with type 2 diabetes.

Further information

Katrine Sperling +45 4442 6718
Ken Inchausti (US) +1 609 786 8316
Peter Hugreffe Ankersen +45 3075 9085
Hanna Ögren +45 3079 8519
Anders Mikkelsen +45 3079 4461
Kasper Veje (US) +1 609 235 8567

Company announcement No 44/2017