Singapore, Dec 27, 2011: Novo Nordisk announced the submission of a new drug application to the Japanese Pharmaceuticals and Medical Devices Agency, PMDA, for the approval of ultra-long-acting insulin Degludec. This new-generation basal insulin has been developed for the treatment of people with type 1 and type 2 diabetes.

“We are very excited about being able to file for regulatory approval of Degludec in Japan,” said Dr Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “This new-generation basal insulin has the potential to fulfill unmet medical needs for millions of people with diabetes who require insulin.”

The Japanese filing is based on results from the BEGIN™ clinical trial programme which involved nearly 7,000 type 1 and type 2 diabetes patients and included Japan in several trials. Data from the trials have shown Degludec to effectively lower blood glucose levels, while also demonstrating a significantly lower rate of hypoglycaemia relative to insulin glargine, especially during the night.

The submission in Japan of a new drug application for DegludecPlus, an insulin formulation containing the ultra-long-acting basal insulin Degludec and the fast-acting insulin NovoRapid®, is expected to take place in the first half of 2012. This will allow for inclusion of clinical data from the recently concluded trial testing DegludecPlus versus insulin glargine both administered once daily as announced on November 7, 2011, in addition to the data from other trials in the BOOST™ programme involving in total more than 3,000 type 1 and type 2 patients.

Source:biospectrumasia.com