Bydureon exenatide regulatory update

EMA said that it is evaluating the potential pancreatic toxicity of glucagon-like peptide-1 (GLP-1) receptor ( GLP-1R; GLP1R) agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors. Last month, FDA said it was evaluating the potential pancreatic toxicity of antidiabetics (see BioCentury, March 18). EMA noted that the European labels for all GLP-1- and DPP-4-based treatments include warnings of pancreatitis. The agency said the risk management plans for the products also instruct marketing authorization holders to "closely monitor for adverse effects on the pancreas."

Both agencies are investigating data published in Diabetes showing that Type II diabetes therapies may be associated with an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia. Specifically, a group of researchers at the University of California, Los Angeles and the University of Florida found that diabetics who received GLP-1- or DPP-4-based therapies (n=8) had about 40% greater pancreatic mass (p<0.05) and significantly increased exocrine cell proliferation (p<0.0001) and pancreatic dysplasia (p<0.01) compared with diabetics who received a different treatment regimen (n=12). The researchers evaluated pancreatic tissue from deceased patients, including non-diabetic controls. ...