The European Medicines Agency, EMA, has concluded that GLP-1 based treatments do not pose new safety concerns for patients with type 2 diabetes.
Earlier this year, a study was published that indicated that drugs based on GLP-1 increase the risk of developing pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia. GLP-1, glucagon-like-peptide-1, is a bodily-specific peptide that lowers the blood sugar level. 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 EMA and the US Food and Drug Administration FDA thus initiated investigations to look into the usage of GLP-1 based therapies.
But the EMA concluded that “presently available data do not confirm recent concerns over an increased risk of pancreatic adverse events with these medicines”. 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. Following an large review of 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 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.