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

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

Company announcement No 3 / 2017