drugset / Press release

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

2017-06-14 · Novo Nordisk A/S · original novonordisk.com ↗

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 Media: Katrine Sperling +45 4442 6718 [email protected] Ken Inchausti (US) +1 609 786 8316 [email protected] Investors: Peter Hugreffe Ankersen +45 3075 9085 [email protected] Hanna Ögren +45 3079 8519 [email protected] Anders Mikkelsen +45 3079 4461 [email protected] Kasper Veje (US) +1 609 235 8567 [email protected] Company announcement No 44/2017

The release as fetched from its publisher. novonordisk.com ↗