Amylin Pharmaceuticals Inc said its resubmission for approval of a diabetes drug was classified by U.S. health regulators as a class 2 response, which typically suggests a review period of six months....
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The U.S. Food and Drug Administration set an action date of Oct. 22 for the drug, tentatively known as Bydureon -- a once-weekly version of diabetes drug Byetta.
The drug, being developed by Amylin and partner Eli Lilly and Co., uses technology from Alkermes, Inc., to release Byetta at a controlled rate.
Bydureon, or exenatide-LAR, is a once-weekly version of the injectable treatment Byetta, which is currently taken twice daily. It is part of the broader GLP-1 class of drugs, which work by increasing the body's insulin production.
The FDA approved Novo Nordisk's once-daily GLP-1 drug Victoza in January. That drug had been under review for two years as safety concerns slowed down the regulatory process. The FDA approved it with a warning over the risk of thyroid cancer.
The companies had responded to the FDA in April, after receiving a complete response letter in March requesting finalization of information to be included in the drug's label, and a risk evaluation and mitigation strategy.
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