Novo Nordisk has submitted a New Drug Application (NDA) for a faster-acting insulin aspart to the US Food and Drug Administration (FDA)
Faster-acting insulin aspart is a mealtime insulin for improved control of postprandial glucose excursions in type 1 and 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 these types of diabetes.
In the onset programme people treated with faster-acting insulin aspart achieved improvements in postprandial (blood sugar) control versus NovoRapid (marketed as NovoLog inside the US) 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.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: "We are happy to be able to file faster-acting insulin aspart for regulatory approval in the US and have the opportunity to address unmet medical needs for people requiring improved blood glucose control around meals.
"Onset 1 shows that faster-acting insulin aspart has the potential to offer improved postprandial glucose and either an additional reduction of HbA1c or added flexibility compared with NovoRapid."
Novo Nordisk has said it intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch.