Pressemitteilung von heute:
Company Announcement
19 October 2012
Tresiba®
(insulin degludec) and Ryzodeg® (insulindegludec/insulin aspart)
receive positive opinions from
the European regulatory authorities
Novo Nordisk today announced that the Committee for Medicinal Products for
Human Use (CHMP) under the European Medicines Agency (EMA) adopted
positive opinions, recommending marketing authorisations, for Tresiba
andRyzodeg® for the treatment of diabetes mellitus in adults.
Tresiba®, the intended brand name for insulin degludec,
is a new generation of once-daily basal insulin. In „treat-to-target‟ studies supporting the new drug application, where Tresiba®
was compared to insulin glargine, Tresibademonstrated a significantly lower risk of overall and nocturnal hypoglycaemia,while successfully achieving equivalent reductions in HbA. Further, with aduration of action beyond 42 hours, Tresiba®1c
is the first basal insulin to offer patients the possibility of adjusting the time of injection, when needed.Ryzodeg®, the intended brand name for insulin degludec/insulin aspart,
contains the new-generation once-daily basal insulin degludec in a soluble
formulation with insulin aspart. Ryzodeg®can be administered once or twice
daily with the main meal(s). In „treat-to-target‟ studies supporting the new
drug application, where Ryzodeg®was compared to NovoMix®®® , Ryzodeg
demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia
while successfully achieving equivalent reductions in HbA.
In Europe, Tresiba® and Ryzodeg®1c will be available in FlexTouch, NovoNordisk‟s latest prefilled insulin pen, which has an easy auto-injector
mechanism. Tresiba®will be offered in two concentrations enabling maximum
doses of 80 and 160 units per injection, respectively.
“We are very happy about the positive opinions from the CHMP. This gives us
confidence, that we soon can make Tresiba®and Ryzodeg® available to many
people with diabetes in Europe,” said Mads Krogsgaard Thomsen, executive
vice president and chief science officer of Novo Nordisk.
Novo Nordisk expects to receive final marketing authorisation from the
European Commission within approximately two months. Subject to the
Commission‟s approval and completion of pricing and reimbursement
discussions, Novo Nordisk expects to launch Tresiba® in a number of Europeanmarkets in the beginning of 2013. Ryzodeg®is currently expected to be
launched approximately one year after Tresiba®, in the respective markets.
About Tresiba®and Ryzodeg®
is the intended brand name for insulin degludec, which is a once-daily
new-generation basal insulin analogue, with an ultra-long-acting 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® is the intended brand name for insulin degludec/insulin aspart,
which contains the new-generation basal insulin degludec in a formulation with
a bolus boost of insulin aspart. Ryzodeg®
is the first and only soluble insulin combination of ultra-long-acting insulin degludec and the most prescribed rapid-acting insulin, NovoRapid® (NovoLog®in the US), providing both fastingand post-prandial glucose control.
Tresiba®and Ryzodeg®
were submitted to the European Medicines Agency
(EMA) and the US Food and Drug Administration (FDA) in September 2011 for
regulatory review. In addition, applications have been submitted for regulatory
approval in Japan, Canada, Switzerland and a range of other countries.
Tresiba®was approved in Japan in September this year.
Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190
countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO).
For more information, visit novonordisk.com.
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