Tresiba® now ready to be launched in Japan

Novo Nordisk today announced that it has received approval of the price of Tresiba® (insulin degludec), the new once-daily basal insulin for the treatment of type 1 and type 2 diabetes, from Japan’s Central Social Insurance Medical Council (Chuikyo), the advisory committee to the Minister of Health, Labour and Welfare.

The price approval allows Novo Nordisk to commercially launch in Japan shortly after Tresiba® is officially posted on Japan’s National Health Insurance price list 22 February.

Tresiba® is a new once-daily basal insulin, which has been discovered and developed by Novo Nordisk. The global clinical programme 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 insulin glargine, Tresiba® successfully achieved equivalent reductions in HbA1c and was associated with significantly lower risk of night-time hypoglycaemia.1,2

In Japan, Tresiba® will be available in FlexTouch®, Novo Nordisk’s latest prefilled insulin pen with an easy push-button. Tresiba® is also available in Penfill®, designed to be used with Novo Nordisk’s insulin delivery systems.

About Tresiba®

Tresiba® is the global brand name for insulin degludec, a new once-daily basal insulin with an ultra-long duration of action3, discovered and developed by Novo Nordisk. Tresiba® has a distinct, slow absorption which provides a flat and stable action profile4. Tresiba® has been studied in a large-scale clinical trial programme, BEGIN®, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust Tresiba® dosing time to suit patient needs. The regulatory process for Tresiba® continues to progress in the major markets. In addition to Japan, Tresiba® has been approved for the treatment of type 1 and type 2 diabetes in Europe and Mexico.

References

1. Zinman B et al., Insulin degludec versus insulin glargine in insulin-naïve patients with type 2 diabetes: A 1-year, randomized, treat-to-target trial (BEGIN Once Long). Diabetes Care, 2012, Dec;35(12):2464-71.
2. Heller S et al., Insulin degludec, an ultra-long-acting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial. Lancet 2012,379 (9825):1489 – 1497.
3. Kurtzhals et al., Multi-hexamer formation is the underlying mechanism behind the ultra-long glucose-lowering effect of insulin degludec. Diabetes 2011;60(Suppl 1): LB12 (Abstract 42-LB).
4. Nosek L et al., Ultra-long-acting insulin degludec has a flat and stable glucose-lowering effect. Diabetes 2011;60(Suppl 1): LB14 (Abstract 49-LB).