Ryzodeg® (insulin degludec/insulin aspart) approved in Japan

Novo Nordisk today announced that the Japanese Ministry of Health, Labour and Welfare has approved Ryzodeg® (insulin degludec/insulin aspart) for the treatment of diabetes.

Ryzodeg® is a soluble formulation of Tresiba® (insulin degludec), a once-daily newgeneration basal insulin analogue with an ultra-long duration of action, and NovoRapid® (insulin aspart which in the US is marketed under the brand name NovoLog®). Ryzodeg® can be administered once or twice daily with the main meal(s). In global „treat-to-target‟ studies supporting the new drug application, where Ryzodeg® was compared to NovoMix®, Ryzodeg® demonstrated a significantly lower risk of nocturnal hypoglycaemia while successfully achieving equivalent reductions in HbA1c.

In Japan, Ryzodeg® 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.

“We are excited about the approval of Ryzodeg®”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The unique properties of Ryzodeg® provide the potential to improve treatment for people with diabetes in Japan”.

About Tresiba® and Ryzodeg®

Tresiba® is the global brand name for insulin degludec, a once-daily new-generation basal insulin analogue with an ultra-long duration of action, 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 programme, BEGIN™, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust Tresiba® dosing time to suit patient needs.

Ryzodeg®, the global brand name for insulin degludec/insulin aspart contains Tresiba®, a once-daily new-generation basal insulin analogue in a formulation with a bolus boost of NovoRapid®. Ryzodeg® is the first and only soluble insulin combination of Tresiba® and the most prescribed rapid-acting insulin, NovoRapid® (NovoLog® in the US), providing both fasting and post-prandial glucose control.

Tresiba® and Ryzodeg® were submitted for regulatory approval to the Japanese Ministry of Health, Labour and Welfare in December 2011 and March 2012, respectively. Tresiba® was approved in Japan in September 2012. In October 2012, Tresiba® and Ryzodeg® received positive CHMP opinions in the EU. In November, the products received a positive vote for approval from an FDA Advisory Committee. In addition, applications have been submitted for regulatory approval in Canada, Switzerland and a range of other countries.