European Commission approves Tresiba r and Ryzodeg (R) for the treatment of diabetes.

Tresiba ®, commercial name of degludec insulin, is an analog of insulin of new generation, which is administered once a day and has a long-term profile. In studies following a methodology of treatment up to target, which were presented to the application for approval of the drug and that Tresiba ® was compared with insulin glargine, Tresiba ® demonstrated a lower risk of overall hypoglycaemia and nocturnal hypoglycemia, at the time that successfully reached the same reductions in HbA1c. In addition, with a duration of more than 42 hours action, Tresiba ® is the first basal insulin that people with diabetes offers the possibility of adjusting the time of injection according to your needs.

For his part, Ryzodeg ®, trade name for degludec/insulin aspart insulin, is composed of analogue basal insulin from new generation degludec in a soluble formulation with insulin aspart. Ryzodeg ® can be administered once or twice daily with the main meals. In studies following a methodology of treatment up to target, which were presented to the application for approval of the drug and that Ryzodeg ® was compared with NovoMix ®, Ryzodeg ® demonstrated a lower risk of significant overall and nocturnal hypoglycemia, at the time that successfully reached the same reductions in HbA1c.

In Europe, both Tresiba ® and Ryzodeg ® are available for commercialization with FlexTouch ®, last prefilled pen developed by Novo Nordisk, which incorporates a mechanism to facilitate the injection. Tresiba ® will be offered in two concentrations, allowing maximum doses of 80 and 160 units by pricking, respectively.

Both of these authorizations are important milestones for Novo Nordisk and treatment of diabetes ”, said Mads Krogsgaard Thomsen, Director of r & d of Novo Nordisk. are looking forward to that Tresiba ® and Ryzodeg ® are available to all people with diabetes in Europe ”

about Tresiba ® and Ryzodeg ®

Tresiba ® is the trade name of insulin degludecanalog basal insulin from new generation of long duration, discovered and developed by Novo Nordisk. Tresiba ® has a ultra slow absorption that provides a flat and stable action profile. Tresiba ® has been studied in a programme of clinical trials to large-scale, BEGIN ®, which has examined its impact on control blood glucose, hypoglycemia and the flexibility to adjust the time of Tresiba ® management to adjust to the needs of the patient.

Ryzodeg ®, commercial name of degludec/insulin aspart insulin, contains Tresiba ®, an analogue of basal insulin from new generation given once a day in a formulation with a rapid bolus of NovoRapid ®. Ryzodeg ® is the first and only combination of Tresiba ® and insulin for more prescribed quick action, ® NovoRapid (NovoLog ® in the United States), which provides basal and postprandial glycemic control.

Tresiba ® and Ryzodeg ® applications for approval by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) were presented in September 2011. In addition, requests have been submitted for approval in Japan, Canada, Switzerland and a large number of countries. Tresiba ® and Ryzodeg ® were approved in Japan in September and December 2012, respectively. In November 2012, products received the positive opinion of the Advisory Committee of the FDA in United States.

Novo Nordisk plans to release Tresiba ® in the United Kingdom and Denmark during the first half of 2013 and in other European markets during 2013 and 2014. In the case of Ryzodeg ®, is expected to launch it a year after Tresiba ®

About Novo Nordisk

with headquarters in Denmark, Novo Nordisk is a global company dedicated to the health care with 89 years of innovation and leadership in diabetes care. The company holds a leading position within areas such as hemostasis control, growth hormone therapy and hormone replacement therapy.