Bydureon Denied Regulatory Approval by the FDA

Last week, in a surprise and, in our view, disappointing move, the FDA decided to not approve Bydureon, a once-weekly GLP-1 agonist, for use in the United States despite seemingly promising clinical trial data. The FDA has asked the makers of the drug (Amylin, Eli Lilly, and Alkermes) to perform an additional study examining the effects of higher than normal blood levels of the drug on the heart, keeping in line with the agency’s recent trend of placing increasing emphasis on the cardiovascular safety of diabetes drugs. With the time needed to conduct this study and for the FDA to review this new data, approval of Bydureon may not come until mid-2012. For further details and in-depth analysis on this decision by the FDA, please see this issue’s Learning Curve. --BK