FDA probes possible higher risk of pancreatitis for newer type 2 diabetes drugs

The US Food and Drug Administration revealed in a web posting yesterday that it is evaluating unpublished new findings that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.

The probe was instigated following a report from researchers at Johns Hopkins of a higher risk of pancreatitis among patients taking this new class of diabetes drugs (The Pharma Letter February 26). The FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.

Drugs in the incretin mimetic class include a number of blockbuster drugs, such as: Eli Lilly's (NYSE: LLY) Byetta, Bydureon (exenatide), which are in the process of being acquired by Bristol-Myers Squibb partnered with AstraZeneca; Novo Nordisk’s (NOV: N) Victoza (liraglutide); Merck & Co’s (NYSE: MRK) sitagliptin brands Januvia, Janumet, Janumet XR, Juvisync; saxagliptin (Onglyza, Kombiglyze XR, also from B-MS); and linagliptin (Tradjenta, Jentadueto from Eli Lilly and Boehringer Ingelheim). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.