Novo Nordisk 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 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®.
