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FDA Approves 'Gila Monster' Diabetes Drug

MedpageToday

ROCKVILLE, Md., April 29-The FDA announced today it has approved a new injectable diabetes drug synthesized from gila monster saliva, but says the drug should only be used in combination with older oral medications.

Eli Lilly of Indianapolis and co-marketer Amylin Pharmaceuticals of San Diego say their new type 2 diabetes drug -- Byetta (exenatide) -- will be in drug stores by June.

The drug, which is an insulin sensitizer, was approved for treatment of type 2 diabetes in combination with older medications such as metformin. The drug is a hormone derived from the saliva of the gila monster.

Action Points

  • The FDA approved Byetta for use in combination with metformin and other oral glycemic control agents for patients whose type 2 diabetes is not well managed with oral agents alone.
  • Advise patients who inquire about this drug that it will not be available until June at the earliest.

Byetta is the first of new class of drugs called incretin mimetics, which mimic the action of GLP-1 (incretin), the peptide hormone that regulates post-prandial insulin production in the gut. In clinical studies submitted to the FDA, combining Byetta with metformin caused an average 1% drop in patients' HbA1C levels, a significant reduction.

The drug has multiple mechanisms of action:

  • It controls glucose concentrations in the blood by suppressing glucagon, which stimulates glucose release from the liver.

  • It stimulates satiety in the brain, which slows the absorption of nutrients into the blood, controlling postprandial glucose "spikes."

  • It stimulates the formation of pancreatic cells.

The drug, however, requires two injections daily, which may be a constraint for some patients who are used to oral medications.

In clinical studies the most common side effect was nausea. Although labeling details are not yet available, the manufacturers said patients using Byetta plus metformin may need to use lower doses of metformin in order to avoid hypoglycemia.

The drug makers are expected to submit additional studies to the FDA to support use of Byetta as stand alone therapy.