EMA ends safety review of GLP-1 diabetes drugs

The European Medicines Agency (EMA) has announced that GLP-1 based treatments pose no new safety concerns for patients with type 2 diabetes .
The regulator has ended its investigation into the safety of the GLP-1 (glucagon-like-peptide-1) class of diabetes drugs four months after launching the safety review in response to research published in the journal Diabetes, which linked the medicines to an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia.
But the EMA concluded that “presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines.
“GLP-1 based therapies are effective treatments for type 2 diabetes and add to the available medication options,” it added.
EMA advisors at the CHMP (Committee for Medicinal Products for Human Use) argued that the research had a number of methodological limitations and potential sources of bias.
“Most importantly [these were] differences between the studied groups with respect to age, gender, disease duration and treatments, which preclude a meaningful interpretation of the results,” they said.
Following an extensive review of all available non-clinical and clinical data, the CHMP decided there was no change in the evidence for the risks of pancreatic adverse events associated with the use of GLP-1 based medications.
The GLP-1 based therapy class includes both GLP-1 agonists and DPP-4 (dipeptidylpeptidase-4) inhibitors, such as Novo Nordisk’s Victoza (liraglutide) and Bristol-Myers Squibb’s Byetta (exanatide).
The CHMP said more information about the risk profile of anti-diabetic drugs, in general will be known next year when the first results of two large independent studies are released.