Amylin’s Bydureon Pen Delayed

The development of a pen device for the once weekly GLP-1 agonist Bydureon (exenatide once-weekly) has hit a snag. Amylin (the drug’s manufacturer) had previously said that the pen would be available by late 2012 or early 2013. In a setback, however, the FDA has requested additional testing data, which is expected to delay the submission and approval of the pen until later next year. As a reminder, GLP-1 agonists are injectable type 2 diabetes drugs that stimulate the body to produce insulin and reduce glucose production only when blood glucose levels are too high. Because of these effects, GLP-1 agonists help improve blood glucose control without increasing the risk for hypoglycemia. GLP-1 agonists also suppress appetite, which can help people lose weight. Besides Bydureon, other currently available GLP-1 agonists include Victoza (Novo Nordisk’s liraglutide) and Byetta (Amylin’s exenatide). While these other drugs require more frequent shots than Bydureon (once a day with Victoza and twice a day with Byetta, compared to once a week with Bydureon), they both come in easy-to-use pen devices. Currently, Bydureon uses a system similar to a glucagon injection, which entails six steps to prepare and inject the drug (click here for a video demonstration). A Bydureon pen is expected to simplify its administration. Although exact details on the pen have not yet been released, injection will likely require three steps: 1) twist the device to combine the drug’s components; 2) shake the pen to mix the drug’s components; and 3) inject the drug. —BK