FDA extends regulatory review period for IDegLira by three months Bagsværd, Denmark, 2 September 2016 - Novo Nordisk today announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for IDegLira, the fixed-ratio combination of insulin degludec and liraglutide in adults with type 2 diabetes.

The FDA informed Novo Nordisk that a three-month extension was required in order to complete its review of the new drug application (NDA) for IDegLira.

Novo Nordisk submitted the NDA to the FDA in September 2015, and with the extension of the review the action date is now expected in December 2016.

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,300 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube

Further information

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

Kasper Veje (US)

+1 609 235 8567

kpvj@novonordisk.com

Novo Nordisk A/S

Investor Relations

Novo Allé

2880 Bagsværd Denmark

Telephone:

+45 4444 8888

Internet: www.novonordisk.com CVR no:

24 25 67 90

Company announcement No 60 / 2016

Novo Nordisk A/S published this content on 03 September 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 05 September 2016 07:15:04 UTC.

Original documenthttp://www.novonordisk.com/bin/getPDF.2039453.pdf

Public permalinkhttp://www.publicnow.com/view/CC6E2C3FCC67AEE7F477F17BE68B11AA27799428