Novo Nordisk
2017-06-14T11:03:48Z
2017-06-14T11:03:48Z
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
| Media: | ||
| Katrine Sperling | +45 4442 6718 | krsp@novonordisk.com |
| Ken Inchausti (US) | +1 609 786 8316 | kiau@novonordisk.com |
| Investors: | ||
| Peter Hugreffe Ankersen | +45 3075 9085 | phak@novonordisk.com |
| Hanna Ögren | +45 3079 8519 | haoe@novonordisk.com |
| Anders Mikkelsen | +45 3079 4461 | armk@novonordisk.com |
| Kasper Veje (US) | +1 609 235 8567 | kpvj@novonordisk.com |
Company announcement No 44/2017