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FDA OKs Lilly-Amylin Drug Byetta for Type 2 Diabetes

Posted: Thursday, May 05, 2005

the drug's developers, Eli Lilly and Co. and Amylin Pharmaceuticals Inc., said.

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 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

Source: Diabetes In Control.com