Supplemental NDA submitted for Byetta for add-on therapy to insulin

Amylin Pharmaceuticals and Eli Lilly announced that a supplemental New Drug Application (sNDA) has been submitted to the FDA for the expanded use of Byetta (exenatide) injection as an add-on therapy to basal insulin, 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. The sNDA is based on a double-blind, placebo-controlled clinical study evaluating Byetta added to Lantus (insulin glargine, from sanofi-aventis). The study showed many hard-to-treat patients with type 2 diabetes who were poorly controlled on basal insulin therapy with or without metformin and/or a TZD achieved HbA1c control without weight gain or increasing their risk of hypoglycemia.

Byetta is a GLP-1 receptor agonist already approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

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