FDA OKs Lizard-Derived Shot for Diabetes
AP | April 29, 2005
WASHINGTON (AP) - Type 2 diabetics got a new option to help control their blood sugar Friday, a drug derived from the saliva of the Gila monster - but one that must be injected twice a day.
The Food and Drug Administration approved Byetta, known chemically as exenatide, the first in a new class of medications for Type 2 diabetes - but for now, it's supposed to be used together with older diabetes drugs, not alone.
Makers Amylin Pharmaceuticals and Eli Lilly & Co. ( LLY ) said the prescription drug would begin selling by June 1, but wouldn't provide a price.
Some 18 million Americans have diabetes, the vast majority the Type 2 form, in which the body loses the ability to turn blood sugar into energy because it either doesn't produce enough insulin or doesn't use it correctly. It is closely associated with obesity.
When diet and exercise aren't enough to control Type 2 diabetes, patients can try certain oral medications to lower blood sugar. The most common, drugs called sulfonylureas, spur the body to produce more insulin.
When those drugs fail, adding Byetta to them offers patients a new option to try before resorting to injections of insulin.
Byetta is the first so-called "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 spur insulin secretion even if blood sugar already is low, leading to the risk of 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, the manufacturers said.
The FDA encouraged the manufacturers to submit additional studies to show whether Byetta could eventually become a stand-alone treatment for Type 2 diabetes.