Amylin Pharmaceuticals says it plans to resubmit its NDA for its once-weekly diabetes drug, Bydureon, in the second half of this year. Amylin has been working with the FDA to create a pathway toward resubmission, the company said, after receiving two complete response letters from the agency. The first letter requested labeling information and a risk evaluation and mitigation strategy as well as clarification of manufacturing processes for the drug. The second letter requested a thorough QT study to measure cardiovascular risk in patients given higher-than-therapeutic doses of Bydureon (exenatide extended-release) and results from a study that evaluated the safety and effectiveness of the drug.
Washington Drug Letter