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

Dienstag, 10.01.2017 14:20

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





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