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UK
10 Jan 2017 14:17 CET

Fiasp® (fast-acting insulin aspart) approved in Europe

Bagsværd, Denmark, 10 January 2017 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Fiasp® for the treatment of diabetes in adults. The authorisation covers all 28 European Union member states.

Fiasp® is the brand name for fast-acting insulin aspart. Fiasp® provides improved mealtime and overall glucose control with a similar safety profile versus NovoRapid®.

"Fiasp® is a new-generation mealtime insulin; it is an innovative faster formulation of insulin aspart that more closely mimics the physiological insulin response around meals. The incremental benefits with Fiasp® are comparable to those observed for the last generation of mealtime insulins when introduced more than a decade ago", said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.

Fiasp® will be available in vial, Penfill® and FlexTouch® pen.

Novo Nordisk expects to launch Fiasp® in the first European countries in the first half of 2017.

About Fiasp®
Fiasp® (fast-acting insulin aspart) is an ultra-fast rapid-acting insulin now approved in Europe that improves 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 earlier, greater and faster 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.

Fiasp® also received marketing authorisation from Health Canada on 6 January 2017, and has been filed for regulatory review in the US, Switzerland, Australia, Canada, Brazil, South Africa and Argentina.

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
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

Company announcement No 3 / 2017