FDA OKs Lizard-Derived Shot for Diabetes

[Guest guest]

FDA OKs Lizard-Derived Shot for Diabetes

Email this Story

Apr 29, 8:58 PM (ET)

By LAURAN NEERGAARD

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

http://finance.myway.com/jsp/qt/short.jsp?symbol_search_text=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. 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.

---

Eli Lilly & Co.: http://www.lilly.com/

Food and Drug Administration: http://www.fda.gov/