Home » Bydureon Suffers Another Setback With Complete Response Letter
Bydureon Suffers Another Setback With Complete Response Letter
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
Washington Drug Letter
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