Novo Nordisk files for regulatory approval of faster-acting insulin aspart in the EU for the treatment of type 1 and 2 diabetes

Bagsvaerd, Denmark, 4 December 2015 - Novo Nordisk today announced the submission to the European Medicines Agency of the Marketing Authorisation Application (MAA) for the approval of faster-acting insulin aspart. Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes.

Novo Nordisk expects to file the new drug application for faster-acting insulin aspart to the US Food and Drug Administration before year-end 2015.  

The filing of faster-acting insulin aspart is based on the results from the 'onset' clinical trial programme which involved around 2,100 people with type 1 and 2 diabetes. In the onset programme, people treated with faster-acting insulin aspart achieved improvements in postprandial control versus NovoRapid ^® and an HbA _1c reduction on par with NovoRapid ^® . For people with type 1 diabetes, faster-acting insulin aspart results from the double-blinded onset 1 trial showed statistically significantly greater HbA _1c reduction when dosed at mealtime or similar HbA _1c reduction when dosed 20 minutes after a meal compared to NovoRapid ^® . Across the onset trials, faster-acting insulin aspart had a safe and well tolerated profile, with the most common adverse event being hypoglycaemia, similar to the levels observed with NovoRapid ^® .  

"With the regulatory filing of faster-acting insulin aspart, we take yet another step in helping people with diabetes improve their blood glucose control around meals," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "Onset 1 shows that faster-acting insulin aspart has the potential to offer improved postprandial glucose and either an additional reduction of HbA _1c or added flexibility compared with NovoRapid ^® ."  

Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch ^® .

About faster-acting insulin aspart

Faster-acting insulin aspart is a mealtime insulin for the control of postprandial glucose excursions in type 1 and type 2 diabetes as well as in pump treatment. Faster-acting insulin aspart is insulin aspart (NovoRapid ^® ) in a new formulation in which two new excipients have been added to ensure early and fast absorption.

About the onset clinical programme

The onset programme is a phase 3 clinical programme with faster-acting insulin aspart consisting of four trials encompassing more than 2,100 people with type 1 and type 2 diabetes.  

The onset 1 trial (1,143 people randomised) - a 26+26-week randomised, double-blinded, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared to NovoRapid ^® , both in combination with Levemir ^® in adults with type 1 diabetes. The results were reported in March and October 2015. 

The onset 2 trial (689 people randomised) - a 26-week randomised, double-blinded, basal-bolus, treat-to-target trial investigating faster-acting insulin aspart compared to NovoRapid ^® , both in combination with insulin glargine in adults with type 2 diabetes. The results were reported in March 2015. 

The onset 3 trial (236 people randomised) - an 18-week randomised, open-label, basal bolus vs basal trial confirming superiority (in terms of HbA _1c ) of mealtime faster-acting insulin aspart in a full basal-bolus regimen versus basal insulin therapy, both in combination with metformin. The results were reported in January 2015. 

The onset 4 trial (37 people randomised) - a six-week randomised, double-blinded, parallel-group trial confirming pump compatibility and safety of faster-acting insulin aspart and NovoRapid ^® in type 1 diabetes. The results were reported in August 2014.

For further information

Company announcement No 75 / 2015