Amylin and Eli Lilly seek expanded diabetes approval By Staff Writer, 3rd March 2006 Pharmaceutical Business Review Online
Amylin Pharmaceuticals and Eli Lilly and Company have submitted a supplemental new drug application to the FDA for the expanded use of their diabetes medication Byetta injection.
The companies are specifically seeking approval for use of their drug as an add-on therapy to a common class of oral diabetes medications called thiazolidinediones, or TZDs, for the treatment of people with type 2 diabetes who are not achieving acceptable blood sugar control.
The drug is already approved as an add-on therapy for treatment of people not achieving acceptable blood sugar control despite using the commonly prescribed diabetes medications metformin, a sulfonylurea or a combination of both.
Byetta is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to regulate blood sugar.
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