Once-weekly Byetta under review
This article was originally published in Pharmaceutical Approvals Monthly
Amylin and partners Lilly and Alkermes announced the submission of their NDA for once-weekly Byetta (exenatide) May 5, with the user fee deadline expected in March 2010. Though there has long been anticipation about the once-weekly version of the incretin mimetic, which is currently dosed twice daily, safety issues have also emerged that could limit its market potential, including pancreatitis. Byetta's sales have dropped, leading Amylin to reduce its sales force detailing the diabetes drug by 200 reps
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