Bydureon Resubmitted for Approval in the US Following Positive Results from a Heart Study

In welcome news, the pharmaceutical companies Amylin, Eli Lilly, and Alkermes announced in early July that Bydureon, a drug for people with type 2 diabetes meant to be injected once weekly, was found to not harm an important aspect of heart function in a recent study. Last fall, the FDA requested that the companies conduct this heart study (called a tQT study) before it would approve the drug for use in the US (see Learning Curve in diaTribe #26). This request had come as a surprise – we had certainly expected approval – and we estimate that by approval, this delay will have cost the company approximately two years in getting the compound to patients. With these results in hand, the companies resubmitted Bydureon to the FDA in late July for approval. Typically, the agency requires six months to review these types of applications, placing the next possible approval date for the drug on or before January 28, 2012. As a reminder, Bydureon belongs to a class of injectable drugs called GLP-1 agonists, which stimulate the body to produce insulin only when blood glucose levels become too high. Two other GLP-1 agonists are currently available in the US (Novo Nordisk’s Victoza and Amylin/Eli Lilly’s Byetta), but in contrast to those drugs, Bydureon lasts longer in the body, allowing the drug to be administered once weekly, and also has a better side effect profile, largely because it causes significantly less nausea than seen with Byetta, the first GLP-1 approved. As we reported last month, Bydureon was approved for use in Europe in June, and people with type 2 diabetes have already begun to use the product in the UK. --BK