Byetta, chemically called exenatide, is the newest option for Type 2 diabetics. The drug is the first of its kind, requires injections twice a day, and presently must be taken along with older diabetes treaments.
Amylin Pharmaceuticals and Eli Lilly & Co. created the drug and announced it will be available for prescription use June 1st - a specific cost has not been addressed publicly.
Byetta is the first "incretin mimetic," meaning it mimics action of a hormone called GLP-1 that's secreted by the gut to spur insulin production after a meal - but only when blood sugar is high.
That's important, noted FDA metabolic drugs chief Dr. David Orloff, because other diabetes drugs induce insulin secretion even if blood sugar is already low - risking hypoglycemia.
Byetta is a synthetic version of a protein found in the saliva of the Gila monster that works similarly to the human GLP-1.
In studies, Byetta was given in addition to sulfonylureas, another common diabetes drug called metformin, or a combination of the older treatments.
Adding Byetta triggered about a 1 percent drop in patients' A1C levels, an important measurement of blood-sugar averages, Orloff said. That's consistent with blood-sugar lowering caused by other diabetes drugs, he said.
The most common side effect was nausea. Also, patients who take Byetta with a sulfonylurea may need doses of that older drug reduced to avoid hypoglycemia, according to manufacturers.
The FDA encouraged the manufacturers to submit additional studies to show whether Byetta could eventually become a stand-alone treatment for Type 2 diabetes.
