Bydureon Suffers Another Setback With Complete Response Letter

October 26, 2010
Eli Lilly, Amylin and Alkermes will need to conduct an additional clinical trial for their once-weekly diabetes drug Bydureon after receiving a second complete response letter from the FDA. The agency is requesting a thorough QT study, used to measure cardiovascular risk, in patients given higher-than-therapeutic doses of Bydureon (exenatide extended-release), Amylin said. The companies will work with the FDA on a study protocol and hope to submit their response by the end of next year. The response will likely be considered a Class II resubmission, meaning a six-month review, Amylin said.
Washington Drug Letter