Amylin, Eli Lilly submit supplemental NDA for diabetes drug Byetta

By Elaine Rigoli

Tampa, Fla., March 1 - Amylin Pharmaceuticals, Inc. and Eli Lilly and Co. announced the recent submission of a supplemental New Drug Application to the Food and Drug Administration to seek approval for expanded use of Byetta (exenatide) injection.

Byetta is an add-on therapy to a common class of oral diabetes medication called thiazolidinediones (TZDs) in people with type 2 diabetes who are not achieving acceptable blood-sugar control, according to a company news release.

Byetta was approved by the FDA in April 2005 for the treatment of type 2 diabetes as add-on therapy in patients who are not achieving acceptable blood sugar control despite using the commonly prescribed diabetes medications metformin, a sulfonylurea or a combination of both, the release said.

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.

Byetta is the first FDA-approved agent of this new class of medications.

Amylin is a biopharmaceutical company based in San Diego.

Eli Lilly is a pharmaceutical products company based in Indianapolis.

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