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Amylin And Lilly Seek Expanded Byetta Approval

From Associated Press (December 22, 2010)

NEW YORK -- Eli Lilly and Co. and Amylin Pharmaceuticals Inc. said Wednesday they are asking the Food and Drug Administration to expand approval for their type 2 diabetes drug Byetta.

The drug makers asked the FDA to approve Byetta for use along with basal insulin, which is insulin that patients take to control their blood sugar levels when they are not eating. The FDA first approved Byetta in April 2005, allowing the companies to market the drug to patients who were taking oral diabetes drugs but did not have their blood sugar under control. In October 2009, it expanded that approval so the companies could market Byetta to patients not using any other medications.

Byetta is approved for use along with diet and exercise. An additional approval could bolster sales as the companies try to get approval for a new, longer-lasting version of the drug.

Eli Lilly, Amylin, and Alkermes Inc. are trying to get FDA approval for a new version of Byetta that is called Bydureon. Bydureon is intended to be injected once a week, compared to Byetta, which is injected twice a day. But the FDA declined to approve Bydureon in October and asked the companies for more data about the drug. The companies say they hope to provide that data by the end of 2011. The FDA will then take at least six months to review the new data.

Revenue from Byetta has slumped since 2008, when the drug was linked to cases of acute pancreatitis.

Shares of Eli Lilly, which is based in Indianapolis, rose 6 cents to $35.20. In aftermarket trading they fell 8 cents to $35.12. Shares of Amylin gained 13 cents to $15.21 Wednesday. The San Diego company’s stock rose 18 cents to $15.39 in aftermarket trading.


Posted: December 2010

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