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

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

Katrine Sperling +45 3079 6718
Ken Inchausti (US) +1 609 786 8316

Peter Hugreffe Ankersen +45 3075 9085
Melanie Raouzeos +45 3075 3479
Hanna Ögren +45 3079 8519
Anders Mikkelsen +45 3079 4461
Kasper Veje (US) +1 609 235 8567

Company announcement No 78 / 2016