The Japanese Ministry of Health, Labour and Welfare has approved Novo Nordisk’s ultra-long acting insulin, insulin degludec, for treatment of diabetes.
Insulin degludec, marketed globally under the name Tresiba, is a new generation of once-daily basal insulin, which has been discovered and developed by Novo Nordisk. Tresiba has a distinct slow absorption which provides a flat and stable action profile.
Tresiba has been studied in a large-scale clinical trial program, BEGIN, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust Tresiba dosing time to suit patient needs.
In Japanese studies, the duration of action for Tresiba was tested up to 26 hours, whereas global studies have shown a duration of action lasting beyond 42 hours.
The global clinical program supporting the new drug application for Tresiba involved close to 10,000 people with type 1 or type 2 diabetes. In the “treat-to-target? studies, where Tresiba
was compared to Lantus (insulin glargine), Tresiba successfully achieved equivalent reductions in HbA1c and was associated with significantly lower risk of nocturnal hypoglycaemia.
In Japan, Tresiba will be available in FlexTouch, Novo Nordisk?s latest prefilled insulin pen, which has an easy auto-injector mechanism and in Penfill for Novo Nordisk?s durable insulin pens.
Novo Nordisk expects to launch Tresiba in Japan as soon as price negotiations have been completed.
Novo Nordisk submitted Tresiba for regulatory approval to the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in September 2011. In addition, applications have been submitted for regulatory approval in a range of other countries.