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
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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Lab-on-a-Chip Offers Promise for TB and Asthma Patients
A device to mix liquids using ultrasonics is the first and most difficult component in a miniaturized system for low-cost analysis of sputum from patients with pulmonary diseases such as tuberculosis and asthma.
Protein Related to Long Term Traumatic Brain Injury Complications Discovered
NIH-study shows protein found at higher levels in military members who have suffered multiple TBIs.
Urine Proteins Point to Early-Stage Pancreatic Cancer
A combination of three proteins found at high levels in urine can accurately detect early-stage pancreatic cancer, researchers at the BCI have shown.
Researcher Discovers Trigger of Deadly Melanoma
New research sheds light on the precise trigger that causes melanoma cancer cells to transform from non-invasive cells to invasive killer agents, pinpointing the precise place in the process where "traveling" cancer turns lethal.
Crystal Clear Images Uncover Secrets of Hormone Receptors
NIH researchers gain better understanding of how neuropeptide hormones trigger chemical reactions in cells.
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
HIV Susceptibility Linked to Little-Understood Immune Cell Class
High levels of diversity among immune cells called natural killer cells may strongly predispose people to infection by HIV, and may be driven by prior viral exposures, according to a new study.
Sweet Revenge Against Superbugs
A special type of synthetic sugar could be the latest weapon in the fight against superbugs.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!