Eli Lilly and Amylin Pharmaceuticals have submitted a supplemental new drug application (sNDA) 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.
Byetta, the first marketed GLP-1 receptor agonist, was approved in the U.S. in April 2005 for the treatment of type 2 diabetes as an add-on therapy to diet and exercise for adult patients not achieving adequate glycemic control using commonly prescribed oral diabetes medications. In October 2009, Byetta was approved as monotherapy along with diet and exercise, according to the San Diego-based Amylin and the Indianapolis-based Lilly.
"Many patients using basal insulin with or without oral diabetes medications are unable to maintain adequate blood sugar control, particularly at mealtime," said Orville G. Kolterman, MD, chief medical officer at Amylin. "If approved for this expanded use, Byetta may provide a complementary addition to basal insulin to improve overall blood sugar control with no weight gain and no increased risk of hypoglycemia."
The sNDA is based on a double-blind, placebo-controlled clinical study evaluating Byetta added to Lantus (insulin glargine), which was published Dec. 7, 2010, in the Annals of Internal Medicine. Nausea was the most common adverse event during the 30-week treatment period and decreased over time.