Novo Nordisk files for new insulin approval
pharmafile | December 10, 2015 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | FDA, NDA, Novo Nordisk, NovoLog, diabetes, insulin aspart, new drug application
Novo Nordisk has submitted a New Drug Application (NDA) for faster-acting insulin aspart to the FDA.
If successful, the Danish firm says it plans to Novo Nordisk intends to make faster-acting insulin aspart available in the prefilled delivery device FlexTouch. It would offer the company another selling point to add to its portfolio of diabetes medicines.
The faster-acting insulin aspart is a mealtime insulin for improved control of blood sugar levels after meals (postprandially), and has been developed for the treatment of people with type 1 and type 2 diabetes. The NDA is for a faster-acting form of Novo Nordisk’s insulin aspart NovoLog, 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 Novo Nordisk’s ONSET clinical trial programme, which involved around 2,100 people with type 1 and 2 diabetes. The studies found that people treated with faster-acting insulin aspart achieved improvements in control of blood sugar after eating, and similar blood sugar reductions compared with, NovoRapid (NovoLog in the United States).
“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,” says 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 HbA1c or added flexibility compared with NovoLog.”
Novartis has announced that the US Food and Drug Administration has approved Fabhalta (iptacopan) as …
Roche has announced that it has entered into a definitive merger agreement with Carmot Therapeutics, …