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CHMP says pancreatic toxicity study flawed

July 27, 2013 12:43 AM UTC

EMA's CHMP said a cadaver study published in March suggesting that glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors -- collectively known as incretin mimetics -- may increase the risk of pancreatic toxicity "had a number of methodological limitations and potential sources of bias" that "preclude a meaningful interpretation of the results." The committee -- which cited differences between studied groups on age, gender and disease duration and treatment -- said all available non-clinical and clinical data do not raise any new concerns about the risks with incretin mimetics. European labels for all GLP-1- and DPP-4-based treatments already include warnings of pancreatitis. Data from European Commission-funded studies evaluating the risk profile of diabetes treatments in general and in relation to the pancreas are expected next spring. ...