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Novo Nordisk insulin analogue gets Japanese nod

02 January 2013 | News | By BioSpectrum Bureau

Novo Nordisk insulin analogue Ryzodeg approved in Japan

Novo Nordisk insulin analogue Ryzodeg approved in Japan

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

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.

Ryzodeg is a soluble formulation of Tresiba (insulin degludec), a once-daily new generation 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 meals. In global 'treat-to-target' studies supporting the new drug application, where Ryzodeg was compared to NovoMix, the former demonstrated a significantly lower risk of nocturnal hypoglycaemia while successfully achieving equivalent reductions in HbA1c.

"We are excited about the approval of Ryzodeg", said Mr 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".

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