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FDA OKs Lilly-Amylin Drug Byetta for Type 2 Diabetes

May 3, 2005
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A drug derived from lizard saliva has been approved by U.S. regulators to treat diabetes in patients who have not responded to other treatments, the drug’s developers, Eli Lilly and Co. and Amylin Pharmaceuticals Inc., said on Friday. See special this week’s feature. Lizard Spit leads to Improved Glucose Control
The drug, exenatide, to be sold under the brand name Byetta, was approved by the U.S. Food and Drug Administration as an add-on therapy for patients with type II diabetes whose blood sugar is not sufficiently controlled by two other treatments, sulfonylurea or metformin or both. The FDA did not approve the drug as a stand-alone treatment.

The drug mimmicks the GLP-1 from the saliva of the Gila monster lizard, which lives in the Arizona desert and eats just four times a year. It is the first of a new class of drugs known as incretin mimetics. Incretin is released in the human gut in response to food.

 

The FDA, while declining to approve the drug as a stand-alone treatment, said any additional data the companies present in order to win approval to sell exenatide as a stand-alone therapy would be reviewed within six months. See this week’s feature: Lizard Spit Improve Glucose Control

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