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

Investigation Into GLP-1 Based Diabetes Therapies Concluded

Published: Friday, July 26, 2013
Last Updated: Friday, July 26, 2013
Bookmark and Share
No new concerns for GLP-1 therapies identified on the basis of available evidence.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has finalised a review of GLP-1-based diabetes therapies. The Committee concluded that presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines.

The rise of type-2 diabetes is a major public health challenge. GLP-1 based therapies are effective treatments for type-2 diabetes and add to the available medication options. The term GLP-1 based therapies comprises two classes of medicines: glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors.

The review of these medicines was initiated following the publication of a study by a group of independent academic researchers that suggested an increased risk of pancreatitis (inflammation of the pancreas) and cellular changes called pancreatic-duct metaplasia in patients with type-2 diabetes treated with so-called GLP-1-based therapies. The findings were based on examination of a small number of pancreatic tissue samples obtained from organ donors with and without diabetes mellitus, who died due to causes other than diabetes.

Following a review of the publication and consultation of a panel of experts, the CHMP considered that the study itself had a number of methodological limitations and potential sources of bias, most importantly differences between the studied groups with respect to age, gender, disease duration and treatments, which preclude a meaningful interpretation of the results.

The CHMP also considered after a review of all available non-clinical and clinical data that there is no change in evidence regarding the risks of pancreatic adverse events associated with the use of GLP-1 based therapies.

A small number of cases of pancreatitis have been reported in clinical trials. In addition, through spontaneous reports a significant number of cases have been observed, although these need to be interpreted cautiously. All these medicines already carry warnings in their product information but the CHMP considered that there would be value in harmonising the wording of these warnings across all GLP-1 based therapies so that patients and healthcare professional receive consistent advice.

With regard to pancreatic cancer, data from clinical trials do not indicate an increased risk with these medicines. However, the number of events is too small to draw final conclusions.  Due to their mechanism of action (stimulation of beta-cell- and suppression of alpha cell-function) some uncertainties remain in respect to the long-term effect of these medicines on the pancreas and more data collection efforts are under way.

The marketing authorisation holders of these medicines are closely monitoring for adverse effects, including effects on the pancreas, and report their findings regularly to the European Medicines Agency (EMA) for assessment. Several studies are planned or ongoing, including large outcome studies which are aimed at increasing the ability to understand and quantify risks associated with these medicines, including the occurrence of pancreatitis and pancreatic cancer, and the potential value of additional studies will also be considered. Marketing authorisation holders will update the risk management plans for these medicines accordingly.

In addition, two large independent studies have been under way since 2011 to study the risk profile of diabetes treatments in general, and more specifically their risk profile in relation to the pancreas. First results of these studies, which are funded by the European Commission, are expected in the spring of 2014.  In the meantime the EMA continues to closely monitor and assess all information that is becoming available on these medicines to ensure that their benefit-risk balance remains positive.


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

EU Drug Regulator Recommends 1st License for Malaria Shot
Mosquirix to be used for vaccination of young children, together with established antimalarial interventions.
Monday, July 27, 2015
European Medicines Agency Launches Adaptive Licensing Pilot Project
Improving timely access for patients to new medicines: pilot explores adaptive licensing approach with real medicines in development.
Friday, March 21, 2014
Scientific News
Therapy Halts Progression of Lou Gehrig’s Disease
Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for nearly two years in one type of mouse model used to study the disease – allowing the mice to approach their normal lifespan.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
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.
UTSW Researchers Identifies How Drugs Alter Pancreatic Cancer Cells
The findings were published in Cell Reports.
Researchers Identify Process that Causes Chronic Neonatal Lung Disease
Study determines how the NLRP3 inflammasome activates the protein Interleukin 1 beta.
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
BRCA1 Deficiency Increases the Sensitivity of Ovarian Cancer Cells to Auranofin
An anti-rheumatic drug could improve the prognosis for ovarian cancer patients exhibiting a deficiency of the DNA repair protein BRCA1, a study suggests.
Shingles Vaccine Helps Protect Older Patients with End-stage Renal Disease
Kaiser Permanente study advances knowledge about safety and effectiveness of vaccine commonly given to older adults.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Scroll Up
Scroll Down
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!