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.
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.
|Katrine Sperling||+45 4442 email@example.com|
|Ken Inchausti (US)||+1 609 786 firstname.lastname@example.org|
|Peter Hugreffe Ankersen||+45 3075 email@example.com|
|Melanie Raouzeos||+45 3075 firstname.lastname@example.org|
|Hanna Ögren||+45 3079 email@example.com|
|Anders Mikkelsen||+45 3079 firstname.lastname@example.org|
|Kasper Veje (US)||+1 609 235 email@example.com|
Company announcement No 3 / 2017
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