Pharmaceutical Business review

FDA approves Lilly drug for expanded diabetes use

The Byetta injection will be used specifically for those diabetes patients who have not achieved adequate control on a thiazolidinedione (TZD).

In a trial designed to evaluate Byetta for use in combination with a TZD, 62% of patients who added Byetta to their existing medicines achieved an A1C (a measure of blood glucose levels over time) of 7% or less, compared to 16% of the patients on placebo. People taking Byetta also lost an average of 3.3 pounds over 16 weeks, compared to an average weight reduction of 0.4 pounds in the other group.

“The combination of exenatide with metformin, sulfonylureas, or TZDs not only expands our options to achieve optimal glycemic control, but does so with accompanying weight loss,” said Dr Robert Ratner, vice president for Scientific Affairs at the MedStar Research Institute in Washington.

Byetta improves blood sugar control by lowering both post-meal and early morning glucose levels. Byetta restores the first-phase insulin response, decreases glucose output from the liver, regulates gastric emptying, and decreases food intake.