(RTTNews) -  Friday after the bell, Amylin Pharmaceuticals, Inc. (AMLN: News ), along with with Eli Lilly & Co. (LLY: News ) announced the U.S. Food and Drug Administration or FDA's approval for expanded indication of their injectable diabetes drug Byetta, to be given as a stand-alone medication to improve glycemic control in patients with type-2 diabetes, when used along with diet and exercise.

Byetta has already been approved by the FDA as a glycemic-control medication in type-2 diabetics using other common diabetes medications and who had not achieved adequate glycemic control.

The approval was based on reports from a clinical study, which proved that the treatment with 5mcg and 10mcg of Byetta reduced average blood sugar levels, measured as A1C levels, by 0.7% to 0.9%, over a three-month period. The study involved patients with type 2 diabetes who were unable to achieve glycemic control through diet and exercise alone. The patients also lost 6.0 pounds and 6.4 pounds, on using the injection, according to the company.

In reporting adverse events from the trial, the company noted that nausea was reported with the greatest incidence, 3% in 5mcg cohort and 13% in 10mcg cohort. Hypoglycemia was reported in 5% of patients taking 5mcg and 4%t of patients taking 10mcg, with no severe hypoglycemic events.

BYETTA is the first and only FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. The drug improves blood sugar levels after food intake through multiple effects on the stomach, liver, pancreas and brain. Used by more than one million patients since introduction in 2005, Byetta has been prescribed in 10 million cases until today, according to the company.
Type-2 diabetes is a disorder characterized by high blood glucose, when the body develops a resistance or a relative deficiency to blood glucose-reducing-hormone, insulin. The condition worsenes the body condition by affecting eyes, feet, kidneys and various other complications in the longer-run. There are an estimated 23.6 million people in the U.S. with diabetes with 17.9 million being diagnosed, 90% of whom are type 2.

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60%of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen. In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese, added the company.

To receive FREE breaking news email alerts for Amylin Pharmaceuticals Inc and others in your portfolio

 1   2   Next Page