Faster-acting NovoRapid (insulin aspart) filed with EMA for diabetes type 1 and 2- Novo Nordisk

Novo Nordisk announced the submission to the European Medicines Agency of the Marketing Authorisation Application (MAA) for the approval of faster-acting NovoRapid (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. Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.

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 HbA1c 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 HbA1c reduction when dosed at mealtime or similar HbA1c 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.