FDA approves expanded use of exenatide injection

October 21, 2011

FDA has approved exenatide (Byetta, Amylin and Eli Lilly) injection as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione, in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

FDA has approved exenatide (Byetta, Amylin and Eli Lilly) injection as an add-on therapy to insulin glargine, with or without metformin and/or a thiazolidinedione (TZD), in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control on insulin glargine alone.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by FDA for the treatment of type 2 diabetes. With this approval, Byetta is now the first and only GLP-1 receptor agonist approved for use in the United States as an adjunct to insulin glargine, with or without certain oral agents.

"This expanded use for Byetta is important for clinical care, in that it provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals," said John Buse, MD, PhD, professor of medicine, director of the Diabetes Care Center and chief of the Division of Endocrinology at the University of North Carolina School of Medicine in Chapel Hill. "Byetta is well-suited for use with insulin glargine, offering a simple fixed-dose regimen that can help improve control of blood sugar overall and after meals. In a clinical trial, patients using Byetta with insulin glargine achieved better glycemic control, without weight gain or an increased risk of hypoglycemia, compared to patients using insulin glargine alone."

In the double-blind study supporting the expanded use, patients receiving insulin glargine, with or without metformin and/or a TZD, were randomly assigned to receive Byetta or placebo in addition to aggressive insulin titration. After 30 weeks of treatment, A1C decreased by 1.7 percentage points in patients adding Byetta, compared with a decrease of 1.0 percentage point in patients treated with insulin glargine alone (P<.001). A1C is a measure of average blood sugar over 3 months. Nausea, which was the most common adverse event, occurred in 41% of patients treated with Byetta compared with 8% of patients treated with insulin glargine alone.

Diabetes affects nearly 26 million people in the United States and an estimated 347 million adults worldwide. Approximately 90% to 95% of those affected have type 2 diabetes. In the United States, diabetes costs more than $174 billion per year in direct and indirect medical expenses.

Byetta is not insulin and should not be taken instead of insulin. Byetta should not be taken with short- and/or rapid-acting insulin. Byetta is not for people with type 1 diabetes or people with diabetic ketoacidosis. It has not been studied in patients with a history of pancreatitis. Other antidiabetic therapies should be considered for these patients.