Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Novo Nordisk Receive Positive Opinions from the European Regulatory Authorities

Published: Tuesday, October 23, 2012
Last Updated: Tuesday, October 23, 2012
Bookmark and Share
The Committee for Medicinal Products for Human Use adopted positive opinions, recommending marketing authorisations, for Tresiba® and Ryzodeg® 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, Tresiba® demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, while successfully achieving equivalent reductions in HbA1c. Further, with a duration of action beyond 42 hours, Tresiba® 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 HbA1c.

In Europe, Tresiba® and Ryzodeg® will be available in FlexTouch®, Novo Nordisk‟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 European markets in the beginning of 2013. Ryzodeg® is currently expected to be launched approximately one year after Tresiba®, in the respective markets.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Novo Nordisk Invests $100M in New Danish Purification Pilot Plant
Company increasing its drug development capacity by investing 550 million Danish kroner in a new research and development facility in Bagsværd, Denmark.
Monday, March 17, 2014
Scientific News
New Biomarker to Assess Stem Cells Developed
A research team led by scientists from UCL have found a way to assess the viability of 'manufactured' stem cells known as induced pluripotent stem cells (iPSCs). The team's discovery offers a new way to fast-track screening methods used in stem cell research.
A Better Model for Parkinson's
Scientists at EPFL solve a longstanding problem with modeling Parkinson’s disease in animals. Using newfound insights, they improve both cell and animal models for the disease, which can propel research and drug development.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
Microalgae Make a Splash in the UK Cosmeceutical Market
Scottish innovators have discovered an anti-viral and anti-inflammatory carbohydrate in microscopic algae (microalgae) which has huge potential to change the cosmetics market.
Mechanism of Tumor Suppressing Gene Uncovered
The most commonly mutated gene in cancer,p53, works to prevent tumor formation by keeping mobile elements in check that otherwise lead to genomic instability, UT Southwestern Medical Center researchers have found.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
Useful Colon Cancer Biomarker Discovered
Biomarker is detectable with simple, inexpensive test.
A New Type of Anticancer Agent
Success in the development of a ?-tubulin specific inhibitor.
Seeing Hope
Gene therapy/drug combo restores some vision in mice with optic nerve injury.
Versatile New Molecule-Building Technique
Chemists at The Scripps Research Institute (TSRI) have devised a new and widely applicable technique for building potential drug molecules and other organic compounds.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!