The announcement was made in a news release by Eli Lilly and Company, which makes Byetta with another drug company, Amylin Pharmaceuticals. Lilly is a WebMD sponsor.
Byetta is not for use for type 1 diabetes. It's only approved for people with type 2 diabetes who need to improve their blood sugar control despite using other drugs (metformin and/or a sulfonylurea), says the Lilly news release.
Drug Derived From Lizard Spit
Byetta is derived from a chemical found in the saliva of the Gila monster, a venomous lizard. The drug is intended to be taken by injection before breakfast and dinner and will be available in June, according to the news release.
Byetta will be available in both a 5-microgram dose and a 10-microgram dose prefilled pen-injector device.
According to the news release, the FDA also says Byetta is "approvable" as a stand-alone therapy for people with type 2 diabetes. That means that the drug is not currently cleared for use alone or as "monotherapy" for patients with type 2 diabetes. A six-month review is expected of any additional data for Byetta as a stand-alone drug, says the news release.
Byetta was tested in three 30-week trials, say the drug's makers. Besides improving blood sugar control, most patients in those studies also lost weight, the news release notes. Treatment with the drug may be associated with a reduced appetite and weight loss.
Side effects were generally mild to moderate in intensity; the most commonly reported being mild-to-moderate, dose-dependent nausea. However with continued therapy this effect subsided over time.
"With continued therapy in most patients who initially experienced nausea, the frequency and severity decreased over time," says the news release.
Patients taking Byetta in combination with a sulfonylurea have an increased risk of low blood sugar (hypoglycemia). "Most episodes of hypoglycemia were mild to moderate in intensity and all were resolved with oral administration of carbohydrate," says the release. "No increased risk of hypoglycemia was seen with Byetta when used in combination with metformin compared to placebo."
An estimated 194 million adults and 18 million in the U.S. have diabetes, and 90% to 95% have type 2 diabetes, says Lilly. Citing CDC statistics, the company says nearly 60% of diabetes patients don't achieve target hemoglobin A1c levels with their current treatment regimen.