EMA concludes: no reason for concerns of pancreatic disease with GLP-1-based therapiesNews - July 31, 2013
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has finalised a review of GLP-1-based therapies. The CHMP concluded that recent concerns over an increased risk of pancreatic adverse events with these medicines are not confirmed by currently available data.
GLP-1-based therapies are effective in the treatment of type 2 diabetes mellitus. Two classes of GLP-1-based medicines exist, namely glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors.
A group of independent academic researchers had published their concerns that GLP-1-treatment in patients with type 2 diabetes might be associated with an increased risk of pancreatitis and pancreatic duct metaplasia . CHMP decided to review these medicines further.
The CHMP concluded, following a review of the publication and consultation of a panel of experts, that the publication expressing the concern suffered from a number of methodological limitations and potential sources of bias. The CHMP furthermore reviewed all available non-clinical and clinical data and concluded that there is no change in evidence regarding the risks of pancreatic adverse events associated with the use of GLP-1 based therapies.
A month ago, the FDA published its conclusions based on a thorough review of all pre-clinical information available from GLP-1-based therapeutic products that are currently on the market or under development. No new concerns were raised with regard to pancreatic disease.
A small number of cases of pancreatitis have been reported in clinical trials. Wording of warnings in product information might be harmonised to provide patients and healthcare professionals with consistent advice. At present, there is no indication that there would be an increased risk of pancreatic cancer, but data is currently too scarce to draw final conclusions .
Adverse effects are currently being monitored by marketing authorisation holders, and more studies, including large outcome studies, are ongoing. This should contribute to the understanding and quantification of the risks associated with the use of this group of medicines.
SourcesPress release European Medicines Agency
Press release ADA/EASD/IDF
1. Butler et al, Marked Expansion of Exocrine and Endocrine Pancreas With Incretin Therapy in Humans With Increased Exocrine Pancreas Dysplasia and the Potential for Glucagon-Producing Neuroendocrine Tumors; Diabetes. 2013 Jul; 62(7):2595-604