Data on Novo Nordisk's Victoza further supporting safety presented at expert workshop

Danish Insulin giant Novo Nordisk (NOV: N) presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the US arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI).

At the two-day workshop, convened as a result of concerns about the safety of incretin-based diabetes therapy (The Pharma Letter June 13), regulators, academic and scientific experts as well as representatives from the pharmaceutical industry came together to discuss suspected mechanisms linking pancreatitis, diabetes and pancreatic cancer.

At the workshop, Solomon Iyasu, director of the division of Epidemiology, US Food and Drug Administration, presented the FDA's approach to address and assess pancreatic safety of the incretin mimetic class of diabetes drugs (GLP-1 receptor agonists and DPP-IV inhibitors). In Dr Iyasu's presentation, the FDA stated that review of epidemiological studies submitted to the FDA and published in journals has provided conflicting results and does not provide reliable evidence to refute or support a causal link between incretin mimetics and the risk of acute pancreatitis. Consequently, the FDA concluded that an evaluation of a potential association between incretin mimetics and pancreatitis and pancreatic cancer would require adequately powered long-term epidemiological studies.