FDA APPROVES AMYLIN, LILLY'S BYETTA FOR COMBINATION USE

Amylin Pharmaceuticals and Eli Lilly announced that the FDA has approved Byetta (exenatide) injection as an add-on therapy to improve blood sugar control in people with Type 2 diabetes who have not achieved adequate control on a thiazolidinedione (TZD).

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

Byetta improves blood sugar control by lowering both post-meal and fasting (early morning) glucose levels, resulting in better long-term control as measured by A1C. The drug controls blood sugar through several physiologic actions, including the stimulation of insulin secretion only when blood sugar is high. Byetta restores the first-phase insulin response (an activity of the cells in the pancreas that is lost in patients who have Type 2 diabetes), decreases glucose output from the liver, regulates gastric emptying and decreases food intake. The majority of patients in long-term Byetta clinical studies experienced weight loss, according to the companies

Byetta is the first in a new class of drugs for the treatment of Type 2 diabetes called incretin mimetics. The drug exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1. It was previously approved as an adjunctive therapy to improve blood-sugar control in patients who have not achieved adequate control with metformin and/or a sulfonylurea.