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2016-11-11

Novo Nordisk A/S: Novo Nordisk receives positive opinion from the European regulatory authorities for Fiasp® (fast-acting insulin aspart) for the treatment of

Bagsværd, Denmark, 11 November 2016
- Novo Nordisk today announced that the Committee for Medicinal Products for
Human Use (CHMP), under the European Medicines Agency (EMA), adopted a
positive opinion for the use of Fiasp®(fast-acting insulin aspart),
recommending marketing authorisation for the treatment of adults with type 1
and type 2 diabetes.

The CHMP recommends Fiasp®, the intended brand name for fast-acting insulin
aspart, to be indicated for use as the bolus component of basal-bolus therapy
in combination with basal insulin and for continuous subcutaneous insulin
infusion via an insulin pump. Novo Nordisk has developed Fiasp®as mealtime
insulin with an earlier and greater glucose-lowering effect than
NovoRapid®(insulin aspart).

"We believe Fiasp®provides an important evolution in mealtime insulin, which
can address the unmet medical need for people requiring further improved
blood glucose control around meals or flexibility of dosing," says Mads
Krogsgaard Thomsen, executive vice president and chief science officer of
Novo Nordisk.

Novo Nordisk expects to receive final marketing authorisation from the
European Commission in the first quarter of 2017.

About Fiasp
®
Fiasp®(fast-acting insulin aspart) is a mealtime insulin for improved control
of postprandial glucose (PPG) excursions and has been developed for the
treatment of people with type 1 and type 2 diabetes, as well as for pump
treatment. Fiasp®is insulin aspart (NovoRapid®) in a new formulation, in
which two new excipients have been added to ensure early and fast absorption
thereby providing earlier insulin action. The review of Fiasp®was based on
the onset programme, a phase 3 clinical programme comprising of four trials
encompassing more than 2,100 people with type 1 and type 2 diabetes.
Further information
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| Media: |
| Katrine Sperling +45 3079 6718 krsp@novonordisk.com |
| Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com |
| Investors: |
| Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com |
| Melanie Raouzeos +45 3075 3479 mrz@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 |
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Company announcement No 78 / 2016

PR161111_Fiasp_CHMP_UK
http://hugin.info/2013/R/2056243/770208.pdf

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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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