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Once Weekly Byetta (Bydureon © ) Delayed 6 Months by the FDA

May 13, 2010

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.

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.

Amylin Pharmaceuticals