Novo Nordisk submits MAA for faster-acting insulin aspart

Novo Nordisk has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency 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. It is insulin aspart (NovoRapid) in a new formulation in which two new excipients have been added to ensure early and fast absorption.

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.  

Novo Nordisk to file new drug application in the US by the end of the year

“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 expects to file the new drug application for the treatment to the US Food and Drug Administration before year-end 2015.