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Novo Nordisk A/S: US FDA accepts Tresiba® and Ryzodeg® resubmissions for review

Bagsværd, Denmark, 7 April 2015 -
Novo Nordisk today announced that the US Food and Drug Administration (FDA)
has accepted for review the Class II Resubmissions for Tresiba®(insulin
degludec) and Ryzodeg®(insulin degludec/insulin aspart).

To preserve the integrity of the ongoing DEVOTE trial, only a small team
within Novo Nordisk has access to the data. This team has prepared the
interim analysis for the Class II resubmission and will interact with the FDA
during the review, on matters related to the interim analysis.

As previously communicated, the result of an interim analysis carries a higher
level of uncertainty than the final study results as this preliminary
estimate is built on a substantially lower number of observations.
Accordingly, the relative risk estimate derived from the interim analysis is
thus only an indication of the final trial results.

Novo Nordisk management does not have access to the results of the interim
analysis. The trial is expected to be completed in the second half of 2016.

For further information

| Media: |
| Katrine Sperling +45 3079 6718 |
| Ken Inchausti (US) +1 609 514 8316 |
| Investors: |
| Kasper Roseeuw Poulsen +45 3079 4303 |
| Melanie Raouzeos +45 3075 3479 |
| Daniel Bohsen +45 3079 6376 |
| Frank Daniel Mersebach (US) +1 609 235 8567 |
Company announcement No 26 / 2015

Company announcement No 25 / 2015


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via Globenewswire


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