Faster-acting insulin aspart filed with FDA for type 1 and type 2 diabetes- Novo Nordisk

Novo Nordisk announced the submission of the New Drug Application (NDA) for faster-acting insulin aspart to the FDA. Faster-acting insulin aspart is NovoLog (insulin aspart) in a new formulation in which two new excipients have been added to ensure early and fast absorption. It offers improved control of postprandial glucose excursions and has been developed for the treatment of people with type 1 and type 2 diabetes.

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 NovoLog (marketed as NovoRapid outside the US) and an HbA1c reduction on par with NovoLog. 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 NovoLog. 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 NovoLog.

Comment: This faster acting form has recently been submitted to the EMA for approval. Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.