Diabetes Drugs Under Scrutiny As FDA Considers Another Study

As a two-day NIH workshop gets underway to examine the safety of several widely used diabetes drugs, the FDA is considering whether to run a study to determine whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that have generated considerable controversy. “A review of FDA-required epidemiological studies submitted to (the FDA) have provided conflicting results and do not provide reliable evidence to refute or support a causal link between GLP-1 based therapies and risk of acute pancreatitis,” wrote Solomon Iyasu, who heads one of the FDA epidemiology divisions, in a synopsis distributed at the NIH meeting. “Additional data mining analysis of the (FDA) adverse events reporting system is unlikely to shed more light on these safety signals. Evaluation of potential association between GLP-1 based therapies and pancreatitis and pancreatic and thyroid cancers will require adequately powered, long term epidemiological studies.” The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia (MRK), which is the biggest seller in this group; Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also marketed by Bristol-Myers; the Tradjena treatment sold by Eli Lilly (LLY) and Boehringer Ingelheim, and Novo Nordisk’s Victoza. The drugs have been under microscope and, in fact, this is the second debate over dia...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs