Woodcock says FDA 'actively investigating' antidiabetics

FDA is actively investigating concerns that glucagon-like peptide-1 (GLP-1) receptor agonists and dipeptidyl peptidase-4 (DPP-4) inhibitors -- collectively known as incretin mimetics -- could cause pancreatitis, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told BioCentury. Responding to a question about the agency's response to concerns about the class of diabetes drugs, Woodcock told BioCentury This Week television that FDA "has been aware of this, and certainly we're doing more investigations." She added that "these are the types of things that need to be resolved as quickly as possible."

The agency is considering requiring additional sponsor studies or an FDA observational study to evaluate the potential pancreatic toxicity of the class, according to Solomon Iyasu, director of CDER's Office of Surveillance and Epidemiology. In a presentation on Thursday at the Pancreatitis-Diabetes-Pancreatic Cancer Workshop, Iyasu noted the limitations in data from both FDA's Adverse Event Reporting System (AERS) and current FDA-required observational studies. He said "adequately powered, long-term epidemiological studies" will be necessary to assess concerns about the class of diabetes drugs. Iyasu also said the agency is requiring that cases of pancreatitis and pancreatic cancer be reported as adverse events of special interest in large cardiovascular outcome trials for GLP-1 therapies. Additionally, the agency is reviewing the results of a post-marketing epidemiological study of pancreatic cancer risk with GLP-1 analog Byetta exenatide from Bristol-Myers Squibb Co. (NYSE:BMY). The workshop was sponsored by NIH's National Cancer Institute and National Institute of Diabetes and Digestive and Kidney Diseases. ...