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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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
Liquid Biopsies: Miracle Diagnostic or Next New Fad?
Thanks to the development of highly specific gene-amplification and sequencing technologies liquid biopsies access more biomarkers relevant to more cancers than ever before.
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
Mutations in DNA-Repair Genes Found in Advanced Prostate Cancers
New findings indicate that nearly 12% of male advanced prostate cancer sufferers have inherited mutation in DNA-repair genes.
Molecule May Affect Gaucher, Parkinson's Disease
Research has identified a molecule that restores activity of a dysfunctional enzyme linked to Gaucher and Parkinson's disease.
Targeting BRAF Mutations in Thyroid Cancer
Treating metastatic thyroid cancer patients harboring a BRAF mutation with vemurafenib showed anti-tumor activity in a third of patients.
Plant Compounds Fight Together Against Colon Cancer
Research shows treating colon cancer cells with curcumin, then silymarin is more effective than treatment with each individually.
New Centre Offers Ultra-Speed Protein Analysis
UW-Madison researchers to establish development centre for next-gen protein measurement technologies.
Drug Candidates Reduce Abnormal Protein Production
New drug candidates improve cell ability to catch miss-folded proteins that could cause deadly diseases.
Supercomputing and Drug Discovery
New biotech company uses supercomputer simulations to speed up drug discovery and biotech molecule development.
Preventing Breast Cancer with Hops
Study of hops extract suggests prevention of breast cancer through chemical pathway activation.
SELECTBIO

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!