Novo Nordisk Files for Approval of Insulin Degludec
Novo Nordisk announced the submission to the U.S. Food and Drug Administration of two new drug applications for ultra-long-acting insulin degludec and the co-formulation, insulin degludec/insulin aspart.
These insulin analogs have been developed for the treatment of people with type 1 and type 2 diabetes.
As with the European applications submitted on Sept. 26, the U.S. filings are based on results from the Begin and Boost clinical trial programs, which involved nearly 10,000 type 1 and type 2 diabetes patients.
Data from the trials have shown insulin degludec to lower blood glucose levels, while demonstrating a low rate of hypoglycemia, especially at night. The trials also showed that insulin degludec can be administered once daily at any time of the day with the possibility to change injection time from day to day according to the needs of the individual patient.
Novo Nordisk intends to make both insulin’s available in a prefilled delivery device. In the clinical trials, insulin degludec was studied in insulin pens that could either deliver up to 80 units or in a concentrated formulation up to 160 units in a single injection.
Release Date: Sept. 29, 2011
Source: Novo Nordisk