Novo Nordisk, a global healthcare company with leadership in diabetes care 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.”
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 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.