Amylin says Byetta gets FDA approval for new use
Amylin Pharmaceuticals Inc said on Friday that its Byetta drug has won U.S. regulatory approval for use as a stand-alone medication to improve glycemic control in adults with type 2 diabetes.
Previously, it only had U.S. Food and Drug Administration approval for use in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.
Byetta has been used by more than one million patients since its 2005 market introduction, Amylin said in the statement.
Byetta, an injected drug, has annual sales of about $700 million. It was the first approved drug from the GLP-1 analog class of Type 2 diabetes medicines that work by stimulating release of insulin only when blood sugar levels are high.
The drug is co-marked with Eli Lilly and Co .
Previously, it only had U.S. Food and Drug Administration approval for use in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.
Byetta has been used by more than one million patients since its 2005 market introduction, Amylin said in the statement.
Byetta, an injected drug, has annual sales of about $700 million. It was the first approved drug from the GLP-1 analog class of Type 2 diabetes medicines that work by stimulating release of insulin only when blood sugar levels are high.
The drug is co-marked with Eli Lilly and Co .
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